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).

Phase 4

• Conditions: patients with a history of a stent thrombosis; 10035534; 10011082

• Registration Number: NL-OMON33697
• Lead Sponsor: Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

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)
Relevant hematologic deviations ( aemoglobin <100g/L (6,2 mmol/L) or hematocrit <34%, platelet count <100 x 109 /L or platelet count > 600 x 109/L)
Known allergy to clopidogrel
Pregnancy (present or suspected)
Uncontrolled hypertension at time of randomization

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified