Status:
TERMINATED
Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Acute Coronary Syndrome
Eligibility:
All Genders
20-74 years
Phase:
PHASE4
Brief Summary
It is standard treatment to take anti-platelet medication after cardiac catheterization and stent placement to help prevent the formation of blood clots that may cause heart attack or stroke. The most...
Detailed Description
Over a three-year period, a total of 7,200 patients undergoing percutaneous coronary intervention (PCI) in whom dual anti-platelet therapy is indicated for at least one year and meet the eligibility c...
Eligibility Criteria
Inclusion
- Males or non-pregnant females between the ages of 20 and 74 years, inclusive
- Not more than four days post-PCI (percutaneous coronary intervention) with placement of one or more drug eluting or bare metal stents
- One or more stent(s) delivered with final TIMI 3 flow (thrombolysis in myocardial infarction grade 3) in the stented vessel(s)
- Must have evidence of one of the following:
- Three vessel disease;
- Two vessel disease with one of the following: estimated creatinine clearance \<60, prior myocardial infarction, diabetes mellitus on treatment, peripheral artery disease, cerebrovascular disease, bifurcation stent, overlapping stents, or total stent deployment length \> 40 mm in length;
- Single vessel disease with two of the following: estimated creatinine clearance \<60, prior myocardial infarction, diabetes mellitus on treatment, peripheral artery disease, cerebrovascular disease, bifurcating stenting, overlapping stents, or total stent deployment length \> 40 mm in length.
- Patients with acute MI (myocardial infarction) preceding the PCI must have CK-MB (bound combination of creatine kinase M and creatine kinase B) value lower than the prior value, before randomization
- Patients with peri-procedural MI, defined by CK-MB three times greater than upper reference limit (URL), must have CK-MB value lower than the prior value, before randomization. Peri-procedural MI will be screened per clinical suspicion.
- Have an indication for one year of dual anti-platelet therapy with a P2Y12 inhibitor and aspirin
- Agreement of the treating physician to prescribe anti-platelet therapy according to randomization and study dosing algorithm
- Ability to understand and comply with planned study procedures
- Provide written informed consent prior to study entry
- Agrees to authorize the collection and release of his/her medical information for the duration of the trial or until the subject withdraws
Exclusion
- History of a gastrointestinal bleed within three months or a major, life threatening bleeding event (e.g., sub-arachnoid or intracranial hemorrhage)
- Active pathological bleeding (e.g. GI bleeding)
- History of bleeding diathesis or coagulopathy
- History of stroke or transient ischemic attack (TIA)
- Non-cardiac surgery within the prior 3 months
- Planned cardiac or non-cardiac surgery within the next 12 months
- CYP2C19 genotype already known to subject or research team from prior genetic testing
- Post-PCI CABG (coronary artery bypass graft) before randomization
- Planned warfarin or dabigatran therapy any time during the study period
- Known allergy to aspirin, clopidogrel or prasugrel
- Platelet count \<100,000/mm3
- Hematocrit \< 25%
- Pregnancy
- Concurrent enrollment in another trial that involves an investigational stent, antithrombotic or anti-platelet agent
- Any condition that would, in the opinion of the site investigator, place them at an unacceptable risk or render them unable to meet the requirements of the protocol
- Any subject, in the opinion of the investigator, not expected to tolerate or be adherent with one year of dual antiplatelet therapy
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01452152
Start Date
February 1 2012
End Date
July 1 2013
Last Update
March 16 2022
Active Locations (5)
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1
Christiana Care Health System
Newark, Delaware, United States, 19718
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
3
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21209
4
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287