Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-29 @ 3:53 PM
Study NCT ID:
NCT03111420
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2017-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AggreGuide A-100 (ADP) Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D010979', 'term': 'Platelet Function Tests'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Platelet function test results are not provided to the participant, care provider, or investigator'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2017-04-02', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Platelet Activity Index (PAI)', 'timeFrame': 'Baseline, day 1, day 7', 'description': 'Platelet reactivity measurement using A-100 ADP assay'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Risk Factor, Cardiovascular', 'Platelet Dysfunction Due to Drugs']}, 'referencesModule': {'references': [{'pmid': '34143384', 'type': 'DERIVED', 'citation': 'Gurbel PA, Tantry US, Bliden KP, Fisher R, Sukavaneshvar S, Dahlen J, Speros PC. Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists. J Thromb Thrombolysis. 2021 Jul;52(1):272-280. doi: 10.1007/s11239-021-02498-0. Epub 2021 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet dysfunction caused by P2Y12 inhibitor antiplatelet therapy.', 'detailedDescription': 'Study subjects will have A-100 ADP measurements performed at baseline and after initiation of P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a history of cardiovascular disease OR\n* Subject has 2 or more cardiac risk factors:\n\n * Smoking\n * Hypertension\n * Hyperlipidemia\n * Family History of Heart Disease\n * Post-menopausal female\n * Diabetes\n * Obesity (BMI \\> 30)\n * Sedentary lifestyle\n\nExclusion Criteria:\n\nTaken nonsteroidal anti-inflammatory drugs (NSAIDs) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the Investigator that would pose safety concerns, or possess contraindications for any of the study medications.'}, 'identificationModule': {'nctId': 'NCT03111420', 'briefTitle': 'Study of AggreGuide A-100 (ADP) Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aggredyne, Inc.'}, 'officialTitle': 'Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs', 'orgStudyIdInfo': {'id': 'VAL-0085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clopidogrel', 'description': 'Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.\n\nLoading dose day 1. Maintenance dose over subsequent 7 days.', 'interventionNames': ['Drug: P2Y12 inhibitor', 'Device: Platelet function test']}, {'type': 'EXPERIMENTAL', 'label': 'Prasugrel', 'description': 'Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.\n\nLoading dose day 1. Maintenance dose over subsequent 7 days.', 'interventionNames': ['Drug: P2Y12 inhibitor', 'Device: Platelet function test']}, {'type': 'EXPERIMENTAL', 'label': 'Ticagrelor', 'description': 'Platelet function test before and after administration of P2Y12 inhibitor antiplatelet therapy after ASA 81 mg.\n\nLoading dose day 1. Maintenance dose over subsequent 7 days.', 'interventionNames': ['Drug: P2Y12 inhibitor', 'Device: Platelet function test']}], 'interventions': [{'name': 'P2Y12 inhibitor', 'type': 'DRUG', 'otherNames': ['clopidogrel', 'prasugrel', 'ticagrelor'], 'description': 'Administration of P2Y12 inhibitor antiplatelet therapy', 'armGroupLabels': ['Clopidogrel', 'Prasugrel', 'Ticagrelor']}, {'name': 'Platelet function test', 'type': 'DEVICE', 'otherNames': ['AggreGuide A-100 ADP assay'], 'description': 'Blood is drawn for testing of platelet aggregation activity', 'armGroupLabels': ['Clopidogrel', 'Prasugrel', 'Ticagrelor']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Phil Speros', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aggredyne, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aggredyne, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}