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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01304472

Enrollment

Registered

2011-02-25

Start date

2011-02-28

Completion date

2011-04-30

Last updated

2011-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

Keywords

coronary angioplasty, clopidogrel resistance, prasugrel

Brief summary

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.

Interventions

DRUGPrasugrel

Prasugrel 10mg per day

DRUGClopidogrel

Clopidogrel 150mg per day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Platelet Reactivity	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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026