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

March 20, 2010 updated by: University of Pecs

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 20, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pecs-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Angina Pectoris

Clinical Trials on clopidogrel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe