NL-OMON33697
Not yet recruiting
Phase 4
The magnitude of platelet inhibition and the pharmacokinetics of a 600 mg loading dose of clopidogrel, in different patient categories (stable angina versus acute-coronary syndromes versus ST-elevated myocardial infarction). - The MAPCAT-study
Cardiology0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- patients with a history of a stent thrombosis
- Sponsor
- Cardiology
- Enrollment
- 200
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Group 1: Patients with a history of a stent thrombosis in the period 2002\-2009\.
- •Group 2: Patients with ACS or stable AP.
Exclusion Criteria
- •Persistent acute ST\-segment elevation
- •Successful revascularization during the qualifying hospitalization, prior to study entry
- •Acute pulmonary edema, hypotension, or evidence of cardiogenic shock
- •Clinically significant liver disease
- •End stage kidney disease requiring dialysis
- •Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4 and CYP3A5 (i.e. clarithromycin, erythromycin, itraconazole, ketoconazole)
- •Contraindications to antithrombotic/antiplatelet therapy
- •Failed coronary intervention in the previous 2 weeks
- •Malignancies
- •Increased risk of bleeding (previous stroke in the past months, active bleeding or bleeding diathesis, recent trauma or major surgery in the last month, suspected aortic dissection, oral anticoagulation therapy with coumarin derivate within 7 days, recent use of GPIIb/IIIa inhibitors within 14 days, severe uncontrolled hypertension \>180 mmHg unresponsive to therapy)
Outcomes
Primary Outcomes
Not specified
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