Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-04-15 @ 12:58 PM
Study NCT ID:
NCT02374957
Status:
TERMINATED
Last Update Posted:
2018-11-23
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cilostazol After Lower Extremity Arterial Revascularization Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medwards@wakehealth.edu', 'phone': '336-716-9343', 'title': 'Dr. Matthew Edwards', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The original principle investigator decided to terminate the study early in order to begin analysis due to his impending departure from Wake Forest Baptist Health.'}}, 'adverseEventsModule': {'timeFrame': '90 days from surgery.', 'description': 'Adverse events include but are not limited to hospitalized CHF, MI, stroke, amputation, pneumonia.', 'eventGroups': [{'id': 'EG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Control', 'description': 'No Cilostazol', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Amputation', 'notes': 'Patients went on to have amputations after initial procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemodialysis', 'notes': 'Patient went on to diaysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other non-CVD', 'notes': 'Renal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected MI', 'notes': 'Patient expired from suspected myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.00', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '15.57', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Six Weeks', 'categories': [{'measurements': [{'value': '12.89', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '12.14', 'spread': '4.53', 'groupId': 'OG001'}]}]}, {'title': 'Six Week Change Score', 'categories': [{'measurements': [{'value': '1.11', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '3.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.\n\nAlternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks.', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with data collected at each pair of time points are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.50', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '16.17', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': 'Three Months', 'categories': [{'measurements': [{'value': '13.75', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '12.50', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': '3 Month Change Score', 'categories': [{'measurements': [{'value': '0.75', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '3.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.\n\nAlternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. . The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with data collected at each pair of time points are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.67', 'spread': '17.32', 'groupId': 'OG000'}, {'value': '42.86', 'spread': '22.33', 'groupId': 'OG001'}]}]}, {'title': 'Six Weeks', 'categories': [{'measurements': [{'value': '60.00', 'spread': '24.37', 'groupId': 'OG000'}, {'value': '71.43', 'spread': '23.40', 'groupId': 'OG001'}]}]}, {'title': '6 Week Change Score', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '21.94', 'groupId': 'OG000'}, {'value': '28.57', 'spread': '27.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.\n\nAlternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Weeks', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.\n\nHigher numbers are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with data collected at each pair of time points are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '57.50', 'spread': '13.89', 'groupId': 'OG000'}, {'value': '41.67', 'spread': '24.22', 'groupId': 'OG001'}]}]}, {'title': 'Three Months', 'categories': [{'measurements': [{'value': '47.50', 'spread': '21.88', 'groupId': 'OG000'}, {'value': '65.83', 'spread': '28.00', 'groupId': 'OG001'}]}]}, {'title': '3 Month Change Score', 'categories': [{'measurements': [{'value': '-10.00', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '24.17', 'spread': '29.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.\n\nAlternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.\n\nHigher numbers are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with data collected at each pair of time points are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.11', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '16.43', 'spread': '10.91', 'groupId': 'OG001'}]}]}, {'title': 'Six Weeks', 'categories': [{'measurements': [{'value': '13.78', 'spread': '9.20', 'groupId': 'OG000'}, {'value': '11.71', 'spread': '7.91', 'groupId': 'OG001'}]}]}, {'title': 'Change Score', 'categories': [{'measurements': [{'value': '-3.33', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '-4.71', 'spread': '11.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.\n\nAlternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Six Weeks', 'description': 'The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.\n\nWith the EACH-Q higher scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with data collected at each pair of time points are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.38', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '15.50', 'spread': '11.64', 'groupId': 'OG001'}]}]}, {'title': 'Three Months', 'categories': [{'measurements': [{'value': '15.25', 'spread': '18.91', 'groupId': 'OG000'}, {'value': '13.00', 'spread': '10.94', 'groupId': 'OG001'}]}]}, {'title': '3 Month Change Score', 'categories': [{'measurements': [{'value': '1.88', 'spread': '17.01', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '12.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.\n\nAlternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.\n\nWith the EACH-Q higher scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients with data collected at each pair of time points are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.\n\nAlternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 days to 259 days', 'description': 'Graft patency was determined by duplex scan as opened or occluded. Follow-up duplex testing ranged from 13 days to 259 days. Number of patency failures (i.e., graft occlusions) are shown below by treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient had no scans to determine graft patency.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Affected by Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Number of Participants affected by Death was reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall survival'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patients Who Had Amputations Following Initial Procedure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Patients who went on to have amputations following initial procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Nineteen patients randomized to either Cilostazol or Control group who had lower extremity revascularization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Had a Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Secondary outcome measure - patients who had a stroke during the 90 day follow up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Claudication Symptoms and Rest Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'OG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'timeFrame': '90 days', 'description': 'Secondary outcome measures including claudication symptoms and rest pain.', 'calculatePct': False, 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected due to early termination of study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'FG001', 'title': 'Control', 'description': 'No Cilostazol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Patient did not complete forms correctly', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.\n\nCilostazol: 100 mg twice daily for 90 days'}, {'id': 'BG001', 'title': 'Control', 'description': 'No Cilostazol'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.60', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '82'}, {'value': '63.11', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '73'}, {'value': '63.37', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 525807, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-24T15:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Original PI left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2015-02-10', 'resultsFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2015-02-23', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-21', 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Affected by Death', 'timeFrame': '90 days', 'description': 'Number of Participants affected by Death was reported'}, {'measure': 'Patients Who Had Amputations Following Initial Procedure.', 'timeFrame': '90 days', 'description': 'Patients who went on to have amputations following initial procedure'}, {'measure': 'Number of Participants Who Had a Stroke', 'timeFrame': '90 days', 'description': 'Secondary outcome measure - patients who had a stroke during the 90 day follow up period.'}, {'measure': 'Claudication Symptoms and Rest Pain.', 'timeFrame': '90 days', 'description': 'Secondary outcome measures including claudication symptoms and rest pain.'}], 'primaryOutcomes': [{'measure': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks', 'timeFrame': 'Baseline and 6 weeks.', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.'}, {'measure': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months', 'timeFrame': 'Baseline and 3 months', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. . The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.'}, {'measure': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.', 'timeFrame': 'Baseline and Six Weeks', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.\n\nHigher numbers are better.'}, {'measure': 'Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.', 'timeFrame': 'Baseline and 3 months', 'description': 'The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled "best imaginable health state" and "worst imaginable health state" with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.\n\nHigher numbers are better.'}, {'measure': 'Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks', 'timeFrame': 'Baseline and Six Weeks', 'description': 'The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.\n\nWith the EACH-Q higher scores are better.'}, {'measure': 'Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months', 'timeFrame': 'Baseline and 3 months', 'description': 'The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from "slow walk" to "running." Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.\n\nWith the EACH-Q higher scores are better.'}], 'secondaryOutcomes': [{'measure': 'Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.', 'timeFrame': '13 days to 259 days', 'description': 'Graft patency was determined by duplex scan as opened or occluded. Follow-up duplex testing ranged from 13 days to 259 days. Number of patency failures (i.e., graft occlusions) are shown below by treatment arm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leg pain', 'claudication'], 'conditions': ['Peripheral Arterial Disease', 'Claudication (Finding)']}, 'descriptionModule': {'briefSummary': 'Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required to adequately power a trial of Cilostazol versus usual care without Cilostazol and its effect on quality of life.', 'detailedDescription': 'Cilostazol is the only medication approved for use in peripheral arterial disease (PAD) patients to reduce claudication symptoms. Contemporary data has demonstrated that Cilostazol improves patency after endovascular interventions in multiple randomized trials and retrospective studies done in Japan in both critical limb ischemia and claudication patients. However, Cilostazol use after peripheral revascularization has been sporadic and there has been no research to estimate patient quality of life with use of Cilostazol after open or endovascular lower extremity revascularization.\n\nThis is a prospective investigator initiated single-center open-label, non-placebo controlled pilot study. Eligible patients would be randomized to either the Cilostazol treatment or the non-Cilostazol treatment groups using a closed envelope randomization technique. Twenty patients will be recruited and randomized; Ten to the treatment group and tento the control group.\n\nThe primary purpose of this pilot study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required for adequate powered trial of Cilostazol versus usual care without Cilostazol and its effect on Quality of Life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 35 years of age\n* Atherosclerotic peripheral arterial disease\n* Able to provide informed consent\n* Lower extremity open or endovascular revascularization.\n\nExclusion Criteria:\n\n* Known CHF (class III/IV)\n* Allergic reaction to phosphodiasterase inhibitors\n* Intracranial bleeding within 3 months or active bleeding peptic ulcer disease\n* Traumatic vascular injuries requiring revascularization\n* Pregnant or breast feeding women or women who plan to get pregnant over the study period\n* Planned ipsilateral major amputation within 30 days of index procedure\n* Moderate to severe hepatic impairment.'}, 'identificationModule': {'nctId': 'NCT02374957', 'acronym': 'CLEAR', 'briefTitle': 'Cilostazol After Lower Extremity Arterial Revascularization Trial', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Cilostazol After Lower Extremity Arterial Revascularization Trial (CLEAR)', 'orgStudyIdInfo': {'id': 'IRB00030275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cilostazol', 'description': 'Administer Cilostazol100 mg twice daily for 90 days.', 'interventionNames': ['Drug: Cilostazol']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No Cilostazol'}], 'interventions': [{'name': 'Cilostazol', 'type': 'DRUG', 'otherNames': ['Pletal'], 'description': '100 mg twice daily for 90 days', 'armGroupLabels': ['Cilostazol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Matthew Edwards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}