Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity (DOSER)

University of Pecs

Status and phase: Terminated; Phase 3

Conditions: Stable Angina Pectoris; Ad Hoc Percutaneous Coronary Intervention

Treatments: Drug: clopidogrel; Drug: clopidogrel plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00638326

Pecs-001

Details and patient eligibility

About

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.

Enrollment: 500 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clopidogrel-naïve stable angina pectoris (CCS I-III)
• Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation

Exclusion criteria

• Acute coronary syndrome (STEMI, NSTEMI or unstable angina)
• Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks
• Contraindication to antiplatelet therapy
• Significant LM stenosis
• PCI due to instent restenosis
• Lesion located in bypass grafts
• Stroke in past one year
• Reduced life expectancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 3 patient groups

1

No Intervention group

Description:

Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel

2

Experimental group

Description:

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days

Treatment:

Drug: clopidogrel

3

Active Comparator group

Description:

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel

Treatment:

Drug: clopidogrel plus placebo