NCT05657041

Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease

Body Weight Adjusted Clopidogrel Treatment in Patients With Coronary Artery Disease

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients with a high BMI/BW have a higher cardiovascular risk and patients with a low BMI/BW seem to have a higher bleeding risk. A high BMI/BW affects the efficacy of clopidogrel. It is not yet known if this clopidogrel efficacy is altered in patients with a low BMI/BW and whether BW-adjusted treatment can optimise this efficacy. We hypothesize that a personalised treatment will eventually lead to a more optimal effect of clopidogrel, optimizing the balance between bleeding and thrombotic risk. This could benefit therapy compliance. Primary Objective: To determine 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 measured using the VerifyNow. Secondary Objective(s): To determine if the CYP2C19 genotype has additional effect on the platelet reactivity in the different treatment groups. This is a non-randomized single centre, prospective, experimental study in patients with CCS treated with clopidogrel 75mg (and aspirin). This study is designed to be pragmatic and is intended to be hypothesis generating. Patients have to be treated with clopidogrel for at least one month without the occurrence of a major bleeding event, an ischemic event (stroke, myocardial infarction, or coronary revascularization) and have to be free of angina complaints. 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.

Conditions

• Coronary Artery Disease
• Platelet Reactivity

Interventions

Type	Name	Description
DRUG	Clopidogrel	Body weight adjusted clopidogrel dosing

Timeline

• Start date: 2023-04-26
• Primary completion: 2024-08-01
• Completion: 2024-11-01
• First posted: 2022-12-20
• Last updated: 2023-06-02

Locations

2 sites across 1 country: Netherlands