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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

Study Description
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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
Coronary Disease Drug: Clopidogrel 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
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Study Type : Interventional  (Clinical Trial)
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 : October 2004
Actual Study Completion Date : July 2005

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U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]

Secondary Outcome Measures :
  1. Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]
  2. P2Y12 inhibition measured by point-of-care test [ Time Frame: P2Y12 inhibition measured by point-of-care test ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140465


Locations
Germany
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00140465     History of Changes
Other Study ID Numbers: GE IDE No. A00803
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
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
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors