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

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Acute Coronary Syndrome Acute Coronary Syndrome (ACS) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cardiology Department, Patras University Hospital

Rio, Patras, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prasugrel

Drug

prasugrel 10 mg/day

clopidogrel

Drug

clopidogrel per os 150mg/day

Primary outcomes

Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)

Time frame: Day 60

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Apr 23, 2010
Registry last updated: Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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