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

Sponsored by:	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

MedlinePlus related topics: Angina Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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

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:	December 2009
Estimated Primary Completion Date:	August 2009 (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

Contacts

Contact: Daniel Aradi, MD

0036302355639

daniel.aradi@kk.pte.hu

Locations

Hungary
Heart Institute, University of Pécs, Dept. of Interventional Cardiology	Recruiting
Pécs, Hungary, 7624
Contact: Ivan Horvath, MD PhD 00363322339 ivan.g.horvath@aok.pte.hu
Sub-Investigator: Balazs Magyari, MD
Sub-Investigator: Erik Kovacs, MD
Sub-Investigator: Attila Konyi, MD
Sub-Investigator: Tunde Pinter, MD

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

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:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00638326
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by University of Pecs:

Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Pain
Ischemia
Thrombosis
Chest Pain

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009