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

NCT ID: NCT01109784

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Coronary Artery Disease (CAD); Acute Coronary Syndrome (ACS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

prasugrel

prasugrel per os 10mg/day

Group Type: EXPERIMENTAL

prasugrel

Intervention Type: DRUG

prasugrel 10 mg/day

clopidogrel

clopidogrel per os 150mg/day

Group Type: ACTIVE_COMPARATOR

clopidogrel

Intervention Type: DRUG

clopidogrel per os 150mg/day

Interventions

prasugrel

prasugrel 10 mg/day

Intervention Type: DRUG

clopidogrel

clopidogrel per os 150mg/day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Patras

OTHER

Sponsor Role: lead

Responsible Party

Patras University Hospital

Locations

Cardiology Department, Patras University Hospital

Rio, Patras, , Greece

Countries

Greece

References

Alexopoulos D, Dimitropoulos G, Davlouros P, Xanthopoulou I, Kassimis G, Stavrou EF, Hahalis G, Athanassiadou A. Prasugrel overcomes high on-clopidogrel platelet reactivity post-stenting more effectively than high-dose (150-mg) clopidogrel: the importance of CYP2C19*2 genotyping. JACC Cardiovasc Interv. 2011 Apr;4(4):403-10. doi: 10.1016/j.jcin.2010.12.011.

Reference Type: DERIVED

PMID: 21511219 (View on PubMed)

Other Identifiers

PATRASCARDIOLOGY-1

Identifier Type: -

Identifier Source: org_study_id