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

Stable Angina Pectoris Clinical Trial

— DOSER  

Official title:

150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00638326
• Other study ID #: Pecs-001
• Status: Terminated
• Phase: Phase 3
• First received: March 11, 2008
• Last updated: March 20, 2010
• Start date: March 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: March 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ad Hoc Percutaneous Coronary Intervention
• Angina Pectoris
• Angina, Stable
• Stable Angina Pectoris

Intervention

Drug:
• clopidogrel
150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
• clopidogrel plus placebo
75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year

Locations

Country	Name	City	State
Hungary	Heart Institute, University of Pécs, Dept. of Interventional Cardiology	Pécs

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.		12 months	No
Secondary	Academic Research Consortium (ARC) definite / probable stent thrombosis		12 months	No
Secondary	Cardiac death and non-fatal myocardial infarction		12 months	No
Secondary	Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding		12 months	Yes
Secondary	5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer		25 +/-2 days	No
Secondary	VASP-PRI		25 +/-2 days	No