Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00670202
Status:
TERMINATED
Last Update Posted:
2017-03-29
First Post:
2008-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C049347', 'term': 'fasudil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anohria@partners.org', 'phone': '617-525-7052', 'title': 'Anju Nohria', 'phoneExt': '617', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was terminated early due to poor enrollment. The patients and physicians remained blinded to study drug assignment for the 2 patients who completed the protocol and no analyses were performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Drug: Fasudil', 'description': 'Fasudil 40 mg three times a day X 14 days\n\nFasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Drug: Placebo', 'description': 'Placebo 1 tablet three times daily x 14 days\n\nPlacebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug: Fasudil Hydrochloride', 'description': 'Fasudil hydrochloride 40 mg three times a day X 14 days\n\nFasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days'}, {'id': 'OG001', 'title': 'Drug: Placebo Oral Tablet', 'description': 'Placebo 1 tablet three times daily x 14 days\n\nPlacebo Oral Tablet: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '>= 2 weeks', 'description': 'We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug: Fasudil', 'description': 'Fasudil 40 mg three times a day X 14 days\n\nFasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days'}, {'id': 'FG001', 'title': 'Drug: Placebo', 'description': 'Placebo 1 tablet three times daily x 14 days\n\nPlacebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Investigators blinded to study drug assignment due to early termination of study', 'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Investigators blinded to study drug assignment due to early termination of study', 'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug: Fasudil', 'description': 'Fasudil 40 mg three times a day X 14 days\n\nFasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days'}, {'id': 'BG001', 'title': 'Drug: Placebo', 'description': 'Placebo 1 tablet three times daily x 14 days\n\nPlacebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days'}, {'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': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', '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': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo controlled, parallel arm design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2008-04-29', 'resultsFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2008-04-30', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-10', 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.', 'timeFrame': '>= 2 weeks', 'description': 'We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients scheduled for elective carotid endarterectomy'], 'conditions': ['Carotid Stenosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with \\>= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy\n* Age \\>= 18 years\n* Agreement of the operating surgeon for patient to participate\n\nExclusion Criteria:\n\n* Surgery scheduled \\< 14 days after randomization\n* Pregnancy\n* ALT, GGT \\> 3x upper limit of normal (ULN)\n* Creatinine \\> 3.5 mg/dL\n* Prior intolerance to statins\n* Reluctance to add or change dosage of statin therapy during study'}, 'identificationModule': {'nctId': 'NCT00670202', 'briefTitle': 'Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy', 'orgStudyIdInfo': {'id': 'P-002369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: Fasudil hydrochloride', 'description': 'Fasudil hydrochloride 40 mg three times a day X 14 days', 'interventionNames': ['Drug: Fasudil Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Drug: Placebo oral tablet', 'description': 'Placebo 1 tablet three times daily x 14 days', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Fasudil Hydrochloride', 'type': 'DRUG', 'otherNames': ['Fasudil'], 'description': 'Fasudil 40 mg three times a day x 14 days', 'armGroupLabels': ['Drug: Fasudil hydrochloride']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days', 'armGroupLabels': ['Drug: Placebo oral tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anju Nohria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Doris Duke Charitable Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Physician in Internal Medicine', 'investigatorFullName': 'Anju Nohria', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}