Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition
The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.
Percutaneous Coronary Intervention
Dual Antiplatelet Therapy
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition|
- MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)
- Rates of major bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
SA + 5mg prasugrel
Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin.
ASA + 10 mg prasugrel
Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin.
ASA + 75 mg clopidogrel daily
Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age >75; Wt< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin.
Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).
|Contact: Roxana Mehran, MDfirstname.lastname@example.org|
|United States, New York|
|Mount Sinai Medical Center||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: George Dangas, MD|
|Principal Investigator:||George Dangas, MD||Mount Sinai School of Medicine|