Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01452152
• Date of registration: 10/10/2011
• Primary sponsor: University of Maryland
• Public title: Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study PAPI-2
• Scientific title: Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study: A Prospective, Multicenter, Randomized Trial of Genotype-directed (G-D)Versus Standard of Care (SOC)Anti-platelet Therapy
• Date of first enrolment: February 2012
• Target sample size: 7200
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT01452152
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Alan R Shuldiner, M.D.
• Affiliation: University of Maryland

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males or non-pregnant females between the ages of 20 and 74 years, inclusive

- Not more than four days post-PCI with placement of one or more drug eluting or bare
metal stents

- One or more stent(s) delivered with final TIMI 3 flow in the stented vessel(s)

- Must have evidence of one of the following:

1. Three vessel disease;

2. 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;

3. 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 preceding the PCI must have CK-MB 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 Criteria:

- 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 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



Age minimum: 20 Years
Age maximum: 74 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Cardiovascular Diseases

Intervention(s)

Drug: clopidogrel

Drug: prasugrel

Primary Outcome(s)

Occurrence of post-randomization cardiovascular events [Time Frame: One year]

Secondary Outcome(s)

Composite of all-cause death, MI, stroke and repeat revascularization [Time Frame: One year]

Health care resource utilization and cost-effectiveness [Time Frame: One year]

Occurrence of adverse events [Time Frame: One year]

Occurrence of bleeding events [Time Frame: One year]

Post-treatment platelet aggregation [Time Frame: 10 days]

Secondary ID(s)

9U01HL105198-06

HP-00047385

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)