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

Primary Purpose

Stable Angina Pectoris, Ad Hoc Percutaneous Coronary Intervention

Status
Terminated
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
clopidogrel
clopidogrel plus placebo
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days

Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel

Outcomes

Primary Outcome Measures

Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.

Secondary Outcome Measures

Academic Research Consortium (ARC) definite / probable stent thrombosis
Cardiac death and non-fatal myocardial infarction
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer
VASP-PRI

Full Information

First Posted
March 11, 2008
Last Updated
March 20, 2010
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT00638326
Brief Title
Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
Acronym
DOSER
Official Title
150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
Greater differences between randomized patients than previously anticipated
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pecs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris, Ad Hoc Percutaneous Coronary Intervention
Keywords
Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Patients who show adequate response to 600 mg loading dose of clopidogrel and receive standard 1x75 mg clopidogrel
Arm Title
2
Arm Type
Experimental
Arm Description
Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x150 mg clopidogrel for 28 days
Arm Title
3
Arm Type
Active Comparator
Arm Description
Patients who show suboptimal response to 600 mg loading dose of clopidogrel and receive 1x75 mg clopidogrel
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year
Intervention Type
Drug
Intervention Name(s)
clopidogrel plus placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Academic Research Consortium (ARC) definite / probable stent thrombosis
Time Frame
12 months
Title
Cardiac death and non-fatal myocardial infarction
Time Frame
12 months
Title
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding
Time Frame
12 months
Title
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer
Time Frame
25 +/-2 days
Title
VASP-PRI
Time Frame
25 +/-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan G Horvath, MD PhD
Organizational Affiliation
Heart Institute, University of Pécs, HUNGARY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Aradi, MD
Organizational Affiliation
Heart Institute, University of Pécs, HUNGARY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andras Komocsi, MD PhD
Organizational Affiliation
Heart Institute, University of Pécs, HUNGARY
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Institute, University of Pécs, Dept. of Interventional Cardiology
City
Pécs
ZIP/Postal Code
7624
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
21902692
Citation
Aradi D, Rideg O, Vorobcsuk A, Magyarlaki T, Magyari B, Konyi A, Pinter T, Horvath IG, Komocsi A. Justification of 150 mg clopidogrel in patients with high on-clopidogrel platelet reactivity. Eur J Clin Invest. 2012 Apr;42(4):384-92. doi: 10.1111/j.1365-2362.2011.02594.x. Epub 2011 Sep 9.
Results Reference
derived
PubMed Identifier
21806387
Citation
Rideg O, Komocsi A, Magyarlaki T, Tokes-Fuzesi M, Miseta A, Kovacs GL, Aradi D. Impact of genetic variants on post-clopidogrel platelet reactivity in patients after elective percutaneous coronary intervention. Pharmacogenomics. 2011 Sep;12(9):1269-80. doi: 10.2217/pgs.11.73. Epub 2011 Aug 1.
Results Reference
derived

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

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