drugset / Trial / NCT05657041

Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease

NCT05657041

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2023-04-26
Primary completion
2024-08-01
Completion
2024-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 25 mg
Subject Clopidogrel Small molecule 75 mg
Subject Clopidogrel Small molecule 150 mg
Subject Prasugrel Small molecule 10 mg