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:
Information provided by:
University of Pecs
ClinicalTrials.gov Identifier:
NCT00638326
First received: March 11, 2008
Last updated: March 20, 2010
Last verified: March 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Academic Research Consortium (ARC) definite / probable stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiac death and non-fatal myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding [ Time Frame: 12 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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Pecs

Additional 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
Study First Received: March 11, 2008
Last Updated: March 20, 2010
Health Authority: Hungary: National Institute of Pharmacy

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

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014