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

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ClinicalTrials.gov Identifier: NCT00140465
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 14, 2007
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen

August 31, 2005
September 1, 2005
November 14, 2007
October 2004
Not Provided
Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]
Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention
Complete list of historical versions of study NCT00140465 on ClinicalTrials.gov Archive Site
  • Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]
  • P2Y12 inhibition measured by point-of-care test [ Time Frame: P2Y12 inhibition measured by point-of-care test ]
  • Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention
  • P2Y12 inhibition measured by point-of-care test
Not Provided
Not Provided
 
75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)
A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2)
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
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Disease
Drug: Clopidogrel
after PCI
Other Names:
  • Iscover
  • Plavix
  • Active Comparator: 1
    75 mg Clopidogrel Maintenance Doses
    Intervention: Drug: Clopidogrel
  • Active Comparator: 2
    150 mg Clopidogrel Maintenance Doses
    Intervention: Drug: Clopidogrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
July 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00140465
GE IDE No. A00803
Yes
Not Provided
Not Provided
Not Provided
Deutsches Herzzentrum Muenchen
Technische Universität München
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
Deutsches Herzzentrum Muenchen
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP