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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Disease | Drug: Clopidogrel | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
75 mg Clopidogrel Maintenance Doses
|
Drug: Clopidogrel
after PCI
Other Names:
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Active Comparator: 2
150 mg Clopidogrel Maintenance Doses
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Drug: Clopidogrel
after PCI
Other Names:
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- Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
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

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
Germany | |
Deutsches Herzzentrum Muenchen | |
Munich, Germany, 80636 |
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 |
ClinicalTrials.gov Identifier: | NCT00140465 |
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 |
Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Clopidogrel 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 |