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

This study has been terminated.
(Greater differences between randomized patients than previously anticipated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638326
First Posted: March 19, 2008
Last Update Posted: March 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Pecs
  Purpose
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.

Condition Intervention Phase
Stable Angina Pectoris Ad Hoc Percutaneous Coronary Intervention Drug: clopidogrel Drug: clopidogrel plus placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Academic Research Consortium (ARC) definite / probable stent thrombosis [ Time Frame: 12 months ]
  • Cardiac death and non-fatal myocardial infarction [ Time Frame: 12 months ]
  • Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding [ Time Frame: 12 months ]
  • 5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer [ Time Frame: 25 +/-2 days ]
  • VASP-PRI [ Time Frame: 25 +/-2 days ]

Estimated Enrollment: 500
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel
Experimental: 2
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
Active Comparator: 3
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

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ivan G. Horvath, Heart Institute, University of Pécs, Dept. of Interventional Cardiology
ClinicalTrials.gov Identifier: NCT00638326     History of Changes
Other Study ID Numbers: Pecs-001
First Submitted: March 11, 2008
First Posted: March 19, 2008
Last Update Posted: March 23, 2010
Last Verified: March 2010

Keywords provided by University of Pecs:
Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors