Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-07 @ 10:56 PM
Study NCT ID:
NCT02201394
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reversing Ticagrelor's Effects With Fresh Platelets
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Juan.Badimon@mssm.edu', 'title': 'Dr. Juan J. Badimon', 'organization': 'Atherothrombosis Research Unit, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study design is partly in vitro as testing of study aims (reversing effects of antiplatelet therapy by adding fresh platelets in different concentrations and at different times) would be nearly impossible using an in vivo study design.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Patients With Stable CVD', 'description': 'DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'P2Y12 Reaction Unit (PRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Loading Dose', 'description': 'Ticagrelor (180 mg) + ASA (325 mg).'}, {'id': 'OG001', 'title': 'Maintenance Dose', 'description': 'Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '284.1', 'spread': '42.2', 'groupId': 'OG000'}, {'value': '284.1', 'spread': '42.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 4 hours 0%', 'categories': [{'measurements': [{'value': '39.1', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '32.4', 'groupId': 'OG001'}]}]}, {'title': '4 hours 25%', 'categories': [{'measurements': [{'value': '69.6', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '38.5', 'groupId': 'OG001'}]}]}, {'title': '4 hours 50%', 'categories': [{'measurements': [{'value': '100.3', 'spread': '49.6', 'groupId': 'OG000'}, {'value': '88.4', 'spread': '42.9', 'groupId': 'OG001'}]}]}, {'title': '4 hours 75%', 'categories': [{'measurements': [{'value': '98.6', 'spread': '54.4', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '49.4', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 6 hours 0%', 'categories': [{'measurements': [{'value': '25.9', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '30.3', 'groupId': 'OG001'}]}]}, {'title': '6 hours 25%', 'categories': [{'measurements': [{'value': '55.3', 'spread': '50.2', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '37.3', 'groupId': 'OG001'}]}]}, {'title': '6 hours 50%', 'categories': [{'measurements': [{'value': '67.8', 'spread': '53.8', 'groupId': 'OG000'}, {'value': '55.4', 'spread': '41.8', 'groupId': 'OG001'}]}]}, {'title': '6 hours 75%', 'categories': [{'measurements': [{'value': '71.2', 'spread': '42.8', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '45.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 24 hours 0%', 'categories': [{'measurements': [{'value': '127.6', 'spread': '58.8', 'groupId': 'OG000'}, {'value': '119.0', 'spread': '78.0', 'groupId': 'OG001'}]}]}, {'title': '24 hours 25%', 'categories': [{'measurements': [{'value': '157.3', 'spread': '52.5', 'groupId': 'OG000'}, {'value': '147.6', 'spread': '65.2', 'groupId': 'OG001'}]}]}, {'title': '24 hours 50%', 'categories': [{'measurements': [{'value': '165.9', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '158.0', 'spread': '43.5', 'groupId': 'OG001'}]}]}, {'title': '24 hours 75%', 'categories': [{'measurements': [{'value': '162.5', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '154.0', 'spread': '51.0', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 48 hours 0%', 'categories': [{'measurements': [{'value': '250.6', 'spread': '45.8', 'groupId': 'OG000'}, {'value': '214.8', 'spread': '74.0', 'groupId': 'OG001'}]}]}, {'title': '48 hours 25%', 'categories': [{'measurements': [{'value': '249.5', 'spread': '35.1', 'groupId': 'OG000'}, {'value': '219.7', 'spread': '52.2', 'groupId': 'OG001'}]}]}, {'title': '48 hours 50%', 'categories': [{'measurements': [{'value': '226.2', 'spread': '51.6', 'groupId': 'OG000'}, {'value': '221.2', 'spread': '44.2', 'groupId': 'OG001'}]}]}, {'title': '48 hours 75%', 'categories': [{'measurements': [{'value': '204.2', 'spread': '45.9', 'groupId': 'OG000'}, {'value': '203.9', 'spread': '41.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose', 'description': 'Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.', 'unitOfMeasure': 'PRU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with stable CVD'}, {'type': 'PRIMARY', 'title': 'Platelet Aggregation Using Multiplate Analyzer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Loading Dose', 'description': 'Ticagrelor (180 mg) + ASA (325 mg).'}, {'id': 'OG001', 'title': 'Maintenance Dose', 'description': 'Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week'}], 'classes': [{'title': 'Baseline (pre-dose', 'categories': [{'measurements': [{'value': '67.0', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 4 hours 0%', 'categories': [{'measurements': [{'value': '13.6', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': '4 hours 25%', 'categories': [{'measurements': [{'value': '18.7', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': '4 hours 50%', 'categories': [{'measurements': [{'value': '21.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': '4 hours 75%', 'categories': [{'measurements': [{'value': '23.6', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 6 hours 0%', 'categories': [{'measurements': [{'value': '12.3', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': '6 hours 25%', 'categories': [{'measurements': [{'value': '17.3', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': '6 hours 50%', 'categories': [{'measurements': [{'value': '20.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': '6 hours 75%', 'categories': [{'measurements': [{'value': '22.3', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Post dose 24 hours 0%', 'categories': [{'measurements': [{'value': '24.9', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '15.6', 'groupId': 'OG001'}]}]}, {'title': '24 hours 25%', 'categories': [{'measurements': [{'value': '39.7', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '35.5', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': '24 hours 50%', 'categories': [{'measurements': [{'value': '49.3', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': '24 hours 75%', 'categories': [{'measurements': [{'value': '52.8', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose 48 hours 0%', 'categories': [{'measurements': [{'value': '41.3', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': '48 hours 25%', 'categories': [{'measurements': [{'value': '57.7', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '56.8', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': '48 hours 50%', 'categories': [{'measurements': [{'value': '68.6', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '63.8', 'spread': '19.1', 'groupId': 'OG001'}]}]}, {'title': '48 hours 75%', 'categories': [{'measurements': [{'value': '72.8', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose', 'description': 'Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU \\* min.', 'unitOfMeasure': '10 AU * min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with stable CVD'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Stable CVD', 'description': 'DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)'}], 'periods': [{'title': 'Loading Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Stable CVD', 'description': 'DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetic', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '4.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '127.2', 'spread': '17.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypercholesterolemia', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cholesterol level', 'classes': [{'categories': [{'measurements': [{'value': '158.7', 'spread': '62.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides level', 'classes': [{'categories': [{'measurements': [{'value': '165.4', 'spread': '91.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL level', 'classes': [{'categories': [{'measurements': [{'value': '85.6', 'spread': '51.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'low-density lipoprotein', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'high-density lipoprotein', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking History', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Past', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Never', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Use', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Past', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Never', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2014-07-24', 'resultsFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-31', 'studyFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P2Y12 Reaction Unit (PRU)', 'timeFrame': 'Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose', 'description': 'Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.'}, {'measure': 'Platelet Aggregation Using Multiplate Analyzer', 'timeFrame': 'Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose', 'description': 'Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU \\* min.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antiplatelet', 'Ticagrelor', 'Platelets', 'Thrombosis', 'Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '28768756', 'type': 'DERIVED', 'citation': 'Zafar MU, Smith DA, Baber U, Sartori S, Chen K, Lam DW, Linares-Koloffon CA, Rey-Mendoza J, Jimenez Britez G, Escolar G, Fuster V, Badimon JJ. Impact of Timing on the Functional Recovery Achieved With Platelet Supplementation After Treatment With Ticagrelor. Circ Cardiovasc Interv. 2017 Aug;10(8):e005120. doi: 10.1161/CIRCINTERVENTIONS.117.005120.'}]}, 'descriptionModule': {'briefSummary': 'Acute coronary syndrome (ACS) patients treated with antiplatelet drugs who require coronary artery bypass grafting (CABG) surgery have to wait 5-7 days for the effects of the drugs to wean off. This treatment-devoid period leaves the patient vulnerable, therefore any means to shorten this period could be useful. The present study aims to investigate the possibility of reversing the antiplatelet effects of ticagrelor with the help of fresh donor platelets. Fresh platelets will be added to blood samples of treated patients in varying concentrations at specific timepoints to determine the time and amount of fresh platelets needed to normalize platelet reactivity in the treated samples.', 'detailedDescription': "The current American College of Cardiology/American Heart Association (ACC/AHA) guidelines for ACS patients requiring CABG surgery after treatment with dual antiplatelet therapy recommend delaying surgery for 5-7 days after discontinuation of therapy, to allow for the dissipation of its antiplatelet effects. This treatment-devoid waiting period puts the ACS patients at risk for further cardiovascular events. Any means to shorten this vulnerable period would be of critical value. One possibility to speed up the recovery of the inhibited platelets is to administer infusions of fresh platelets. In fact, platelet transfusions are frequently administered to patients during surgery who had received prior antiplatelet therapy. However, the degree to which these transfusions restore platelet function in the recipient subjects' blood and the time from dosing when they are most effective are unknown. The timing is critical in scenarios where urgent surgery is required because infusion of platelets too soon after antiplatelet dosing could render them useless by the residual drug in circulation.\n\nThe aim of the present study is to investigate the restoration of platelet function of ticagrelor-treated subjects by adding donor platelets to their blood. The study would have 2 arms mimicking different clinical scenarios:\n\n1. Clinical Scenario 1 - Patient given a loading dose (LD) of ticagrelor in the emergency room, requires surgery: A single LD of ticagrelor (180 mg) with aspirin (325 mg) will be given to study subjects and platelet testing will be performed after addition of fresh platelets to their blood ex vivo. Donor platelets will be added at 4-, 6-, 24- and 48-hours post-dose, to assess the time required for normalizing subject's platelet function after a LD of ticagrelor.\n2. Clinical Scenario 2 - Patient on maintenance dosing (MD) of ticagrelor, requires surgery: Subjects will receive ticagrelor (90 mg twice daily) with aspirin (81 mg once daily) for 3-7 days. After the last dose, platelet testing will be performed after addition of fresh platelets to their blood ex vivo, at 4-, 6-, 24- and 48-hours post-dose to assess the time required for normalizing subject's platelet function after daily treatment with ticagrelor.\n\nPlatelet testing will be carried out using the following methodologies:\n\n1. Platelet Aggregation - VerifyNow P2Y12 assay.\n2. Platelet Aggregation - Multiplate Analyzer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female volunteer between 18 and 75 years old.\n* History of stable (i.e. non-acute) cardiovascular disease or the presence of risk factors for cardiovascular disease (i.e. hypertension, diabetes, hyperlipidemia, high calcium score and abnormal findings on angiography or stress test).\n\nExclusion Criteria:\n\n* Conditions associated with hemorrhagic risk, e.g., frequent epistaxis, gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.\n* Allergy or hypersensitivity to aspirin or ticagrelor.\n* Loss of \\>400 mL blood or blood donation within past 3 months.\n* Positive serology for hepatitis B (HBs Ag) or hepatitis C.\n* History of drug abuse or alcohol abuse.\n* Positive pregnancy test.\n* Evidence of unstable or acute cardiovascular disease (e.g., unstable angina, recent myocardial infarction, congestive heart failure).\n* History of clinically relevant pulmonary, hepatic, gastrointestinal, renal, metabolic, hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute infectious disease or signs of acute illness.'}, 'identificationModule': {'nctId': 'NCT02201394', 'briefTitle': "Reversing Ticagrelor's Effects With Fresh Platelets", 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Normalizing Platelet Reactivity After Treatment With Ticagrelor', 'orgStudyIdInfo': {'id': 'GCO 13-1802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loading dose', 'description': 'Patients with stable CVD given a single ticagrelor loading dose and aspirin loading dose', 'interventionNames': ['Drug: Ticagrelor loading dose', 'Drug: Aspirin loading dose']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance dose', 'description': 'Patients with stable CVD given ticagrelor maintenance dose and aspirin maintenance dose for one week.', 'interventionNames': ['Drug: Ticagrelor maintenance dose', 'Drug: Aspirin maintenance dose']}], 'interventions': [{'name': 'Ticagrelor loading dose', 'type': 'DRUG', 'otherNames': ['Brilinta'], 'description': 'Single loading dose of Ticagrelor 180 mg', 'armGroupLabels': ['Loading dose']}, {'name': 'Aspirin loading dose', 'type': 'DRUG', 'otherNames': ['Acetylsalicylic acid', 'ASA'], 'description': 'Single loading dose of Aspirin 325 mg', 'armGroupLabels': ['Loading dose']}, {'name': 'Ticagrelor maintenance dose', 'type': 'DRUG', 'otherNames': ['Ticagrelor', 'Brilinta'], 'description': 'Ticagrelor 90 mg twice daily x 7 days', 'armGroupLabels': ['Maintenance dose']}, {'name': 'Aspirin maintenance dose', 'type': 'DRUG', 'otherNames': ['Aspirin', 'ASA'], 'description': 'Aspirin 81 mg once daily x 7 days', 'armGroupLabels': ['Maintenance dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Juan J Badimon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, AtheroThrombosis Research Unit; Professor of Medicine', 'investigatorFullName': 'Juan J Badimon', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}