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75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Completed
CT.gov ID
NCT00140465
Collaborator
Technische Universität München (Other)
60
Enrollment
1
Location
2
Arms
9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300 to 600 mg loading dose. In the CREDO trial it was shown that a 300 mg loading dose results in a reduction of ischemic events after percutaneous coronary intervention (PCI) if given 6 hours prior to the procedure. An antiplatelet effect similar to that achieved by chronic therapy with 75 mg/day is reached within 2 hours when the high 600 mg loading is administered. The 600 mg loading dose has been shown to be safe and effective in preventing thrombotic events following coronary stent implantation. Recently, it was shown that in patients with stable angina and administration of the 600 mg loading dose at least two hours prior to PCI concomitant therapy with a GP IIb/IIIa antagonist does not result in a further reduction of the incidence of thrombotic events. In contrast to a number of investigations with different loading doses, no trials have been performed comparing different clopidogrel maintenance doses. Recently, it was shown that administration of a 600 mg loading dose in patients already on chronic clopidogrel therapy (75 mg/day) results in an additional significant increase in inhibition of adenosine diphosphate (ADP-) induced platelet aggregation. Therefore, it is possible that an increase of the clopidogrel maintenance dose in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of platelet aggregation.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2)
Study Start Date :
Oct 1, 2004
Actual Study Completion Date :
Jul 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

75 mg Clopidogrel Maintenance Doses

Drug: Clopidogrel
after PCI
Other Names:
  • Iscover
  • Plavix

    		•
    Active Comparator: 2

    150 mg Clopidogrel Maintenance Doses

    Drug: Clopidogrel
    after PCI
    Other Names:
  • Iscover
  • Plavix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention [30 days after the intervention]

    Secondary Outcome Measures

    1. Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention [30 days after the intervention]

    2. P2Y12 inhibition measured by point-of-care test [P2Y12 inhibition measured by point-of-care test]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with chronic aspirin therapy who are treated with percutaneous coronary intervention at least 2 hours after administration of a 600 mg loading dose of clopidogrel
    Exclusion Criteria:

    • Major alterations of blood count (particularly platelet count < 100x10^9/l, haemoglobin < 10 mg/dl

    • Recent bleeding diathesis

    • Presence of a hematologic or malignant disorder

    • Oral anticoagulation with coumarin derivates

    • Use of glycoprotein (GP) IIb/IIIa antagonists during the intervention or during the preceding 14 days

    • Therapy with clopidogrel within the last 28 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deutsches Herzzentrum Muenchen Munich Germany 80636

    Sponsors and Collaborators

    • Deutsches Herzzentrum Muenchen
    • Technische Universität München

    Investigators

    • Study Chair: Albert Schomig, MD, Deutsches Herzzentrum Muenchen
    • Study Director: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
    • Principal Investigator: Nicolas von Beckerath, MD, Deutsches Herzzentrum Muenchen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00140465
    Other Study ID Numbers:
    • GE IDE No. A00803
    First Posted:
    Sep 1, 2005
    Last Update Posted:
    Nov 14, 2007
    Last Verified:
    Nov 1, 2007
    Additional relevant MeSH terms:
    Coronary Disease
    Clopidogrel

    Study Results

    No Results Posted as of Nov 14, 2007