Heart Attack Research Program: Platelet Sub-Study (HARP)
NCT ID: NCT03022552
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
350 participants
OBSERVATIONAL
2020-07-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MINOCA
Women with myocardial infarction (MI) with demonstrated non-obstructive coronary artery disease during cardiac catheterization (less than 50% blockage in any major vessel).
No interventions assigned to this group
MI-CAD
Women with myocardial infarction (MI) with demonstrated obstructive coronary artery disease during cardiac catheterization (50% or greater blockage in any major vessel) or previous history of percutaneous coronary intervention (PCI) or or coronary artery bypass graft (CABG).
No interventions assigned to this group
CATH-NOCA
Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Objective evidence of MI (either or both of the following):
* Elevation of troponin to above the laboratory upper limit of normal (ULN)
* ST segment elevation of ≥1mm on 2 contiguous ECG leads
* Willing to provide informed consent and comply with all aspects of the protocol
* Administration of aspirin at least 1 hour before cardiac catheterization
* Administration of thienopyridine (e.g., clopidogrel, ticagrelor) at least 1 hour before cardiac catheterization
* Women and men with ≥50% of any major epicardial vessel on invasive angiography may participate
Exclusion Criteria
* Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma
* Pregnancy
* Thrombolytic therapy for STEMI (qualifying event)
* Use of any of the following medications:
* Platelet antagonists (except aspirin and thienopyridines) within 7 days
* NSAIDs (e.g., ibuprofen, naproxen) within 3 days.
* Thrombocytopenia (platelet count \<100,000)
* Thrombocytosis (platelet count \>500,000)
* Anemia (hemoglobin \<9 mg/dl)
* Hemorrhagic diathesis
21 Years
99 Years
FEMALE
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Harmony R Reynolds, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Locations
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NYU Langone Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffrey Berger, MD
Role: primary
References
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Sowa MA, Hannemann C, Pinos I, Ferreira E, Biwas B, Dai M, Corr EM, Cornwell MG, Drenkova K, Lee AH, Spruill T, Reynolds HR, Hochman JS, Ruggles KV, Campbell RA, van Solingen C, Wright MD, Moore KJ, Berger JS, Barrett TJ. Tetraspanin CD37 regulates platelet hyperreactivity and thrombosis. Cardiovasc Res. 2025 Jun 12;121(6):943-956. doi: 10.1093/cvr/cvaf051.
Barrett TJ, Corr EM, van Solingen C, Schlamp F, Brown EJ, Koelwyn GJ, Lee AH, Shanley LC, Spruill TM, Bozal F, de Jong A, Newman AAC, Drenkova K, Silvestro M, Ramkhelawon B, Reynolds HR, Hochman JS, Nahrendorf M, Swirski FK, Fisher EA, Berger JS, Moore KJ. Chronic stress primes innate immune responses in mice and humans. Cell Rep. 2021 Sep 7;36(10):109595. doi: 10.1016/j.celrep.2021.109595.
Barrett TJ, Lee AH, Smilowitz NR, Hausvater A, Fishman GI, Hochman JS, Reynolds HR, Berger JS. Whole-Blood Transcriptome Profiling Identifies Women With Myocardial Infarction With Nonobstructive Coronary Artery Disease. Circ Genom Precis Med. 2018 Dec;11(12):e002387. doi: 10.1161/CIRCGEN.118.002387. No abstract available.
Other Identifiers
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16-01104-3
Identifier Type: -
Identifier Source: org_study_id
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