Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease
Status:
Not yet recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Extreme body weights (BW) or body mass index (BMI) affect the pharmacokinetics of
antithrombotic drugs and consequently may affect cardiovascular risk during treatment. The
goal of this clinical trial is to establish if clopidogrel treatment can be optimized in
patients with a low or high BW compared to patients with a normal BW by adjusting the dosage
of clopidogrel and evaluating platelet reactivity.
Participants are stratified into three groups based on their BW (Low BW: BW <60kg; normal BW:
60-100kg; High BW: >100 kg)
Clopidogrel dosage will then be adjusted to the BW, as follows:
- Low BW: >10 days clopidogrel 50mg 1dd1, followed by >10 days clopidogrel 25mg 1dd1.
- Normal BW: Clopidogrel 75mg 1dd1.
- High BW: >10 days clopidogrel 150mg 1dd1 followed by >10 days prasugrel 10mg 1dd1.
The primary endpoint of the study is P2Y12 Reaction Units (PRU) and platelet inhibition
measured using the VerifyNow measured before starting new treatment regimen (at the end of 10
days of treatment).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
St. Antonius Hospital
Collaborators:
Ace pharmaceuticals Allgen pharmaceuticals St. Antonius hospital Onderzoeksfonds