Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dimitrios Alexopoulos, Pátrai, 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 with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
Written Informed Consent

Exclusion criteria

History of bleeding diathesis
History of active bleeding within 6 months before randomization
Chronic oral anticoagulation treatment
Contraindications to antiplatelet treatment
Known platelet function disorders
Acute coronary syndrome within 30 days before randomization
Cardiogenic shock
Planned Percutaneous Coronary Intervention in the next 30 days
Cancer
Haemodialysis
Platelet count < 100000/μL
Hematocrit < 30%
High likelihood of being unavailable on the Day 28 visit
History of stroke
Known allergy to clopidogrel and/or prasugrel

Treatment and study plan

Prasugrel

Drug

Prasugrel 10mg per day

clopidogrel

Drug

Clopidogrel 150mg per day

Primary outcomes

Change in Platelet Reactivity

Time frame: At 14 and 28 days after randomization

Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Feb 25, 2011
Registry last updated: Aug 23, 2011

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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