Doubling the Maintenance Dose of Clopidogrel After Percutaneous Coronary Intervention in Low Responders to Therapy - Full Text View

Sponsor:	University of Pecs
Information provided by:	University of Pecs
ClinicalTrials.gov Identifier:	NCT00638326

Purpose

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the 9-month incidence of thromboischemic events compared to 75 mg clopidogrel after elective percutaneous coronary intervention.

Condition	Intervention	Phase
Stable Angina Pectoris Percutaneous Coronary Intervention	Drug: clopidogrel Drug: clopidogrel plus placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Doubling the Maintenance Dose of Clopidogrel After Percutaneous Coronary Intervention in Low Responders to Therapy

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by University of Pecs:

Primary Outcome Measures:

Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Academic Research Consortium (ARC-1) definite stent thrombosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Cardiac death or non-fatal myocardial infarction or ischemia-driven target lesion revascularisation or TIMI major/minor bleeding [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer [ Time Frame: 25 +/-2 days ] [ Designated as safety issue: No ]
VASP-PRI [ Time Frame: 25 +/-2 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel
2: Experimental Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days	Drug: clopidogrel 150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
3: Active Comparator Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel	Drug: 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

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638326

Locations

Hungary
Heart Institute, University of Pécs, Dept. of Interventional Cardiology
Pécs, Hungary, 7624

Sponsors and Collaborators

University of Pecs

Investigators

Principal Investigator:	Ivan G Horvath, MD PhD	Heart Institute, University of Pécs, HUNGARY
Study Director:	Daniel Aradi, MD	Heart Institute, University of Pécs, HUNGARY
Study Chair:	Andras Komocsi, MD PhD	Heart Institute, University of Pécs, HUNGARY

More Information

No publications provided

Responsible Party:	Heart Institute, University of Pécs, Dept. of Interventional Cardiology ( Ivan G. Horvath )
Study ID Numbers:	Pecs-001
Study First Received:	March 11, 2008
Last Updated:	January 17, 2010
ClinicalTrials.gov Identifier:	NCT00638326 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by University of Pecs:

Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

Additional relevant MeSH terms:

Heart Diseases
Ticlopidine
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Angina Pectoris
Vascular Diseases
Fibrinolytic Agents
Pain

Cardiovascular Agents
Pharmacologic Actions
Chest Pain
Signs and Symptoms
Fibrin Modulating Agents
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010