Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT01109784

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

23.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease (CAD) Acute Coronary Syndrome (ACS)	Drug: prasugrel Drug: clopidogrel	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prasugrel prasugrel per os 10mg/day	Drug: prasugrel prasugrel 10 mg/day
Active Comparator: clopidogrel clopidogrel per os 150mg/day	Drug: clopidogrel clopidogrel per os 150mg/day

Arm

Intervention/Treatment

Experimental: prasugrel

prasugrel per os 10mg/day

Drug: prasugrel

prasugrel 10 mg/day

Active Comparator: clopidogrel

clopidogrel per os 150mg/day

Drug: clopidogrel

clopidogrel per os 150mg/day

Outcome Measures

Primary Outcome Measures

Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics) [Day 60]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years old
Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
Written Informed consent
Platelet reactivity units (PRU) (VerifyNow) >230

Exclusion Criteria:

A history of bleeding diathesis
Chronic oral anticoagulation treatment
Contraindications to antiplatelet therapy
Known platelet function disorders
PCI or coronary artery bypass surgery < 3 months
Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
Planned staged PCI in the next 60 days
Hemodynamic instability
Cancer or hemodialysis
Platelet count <100 000/ μL, hematocrit <30%
Creatinine clearance <25 ml/min
A life expectancy<1 year, inability to give informed consent
High likelihood of being unavailable for the Day 60 follow up