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

Coronary Artery Disease (CAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109784
• Other study ID #: PATRASCARDIOLOGY-1
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2010
• Last updated: August 23, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: April 2010
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• prasugrel
prasugrel 10 mg/day
• clopidogrel
clopidogrel per os 150mg/day

Locations

Country	Name	City	State
Greece	Cardiology Department, Patras University Hospital	Rio, Patras

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)		Day 60	No