Body Weight Adjusted Clopidogrel treatment in patients with CORonary artery Disease (BW-ACCORD)

Phase 4

Recruiting

• Conditions: chronic coronary syndrome; coronary artery disease; stable coronary artery disease; 10011082

• Registration Number: NL-OMON53494
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

- Patients, male or female, >=18 years of age
- Patients treated for coronary artery disease with clopidogrel 75mg QD
(aspirin 100mg QD).
- Patients must be treated with clopidogrel 75mg for at least one month
- Patients must give consent by means of a signed informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

- Contra-indication for aspirin
- Contra-indication for clopidogrel or prasugrel
- Occurrence of an ischemic event after PCI or ACS (stroke, myocardial
infarction, or coronary revascularization)
- Presence of unstable angina complaints.
- Presence of two CYP2C19 Loss-of-function (LOF) alleles (*2 or *3)
- Scheduled for cardiac valve surgery
- Indication for chronic oral anticoagulants
- Expected life span of less than one year
- Pregnancy
- Suboptimal stent placement as determined by the cardiologist.
- Patients at increased risk of bleeding with two of the following
characteristics: liver cirrhosis with portal hypertension, enhanced bleeding
tendency, active malignancy in the past 12 months, thrombocytopenia, major
surgery in the past month, spontaneous intracerebral haemorrhage, traumatic
intracerebral haemorrhage in the past 12 months, major bleeding requiring
hospitalisation or blood transfusion in the past month, ischaemic CVA in the
past 5 months.
- Known with established stent thrombosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the level of platelet reactivity, measured as<br /><br>Platelet Reaction Unit (PRU) as measured by the VerifyNow system in the<br /><br>different treatment groups and different treatment regimens.<br /><br>HTPR will be assessed, defined by a PRU >208.<br /><br>PRU values in the low and high BW/BMI group will be compared to the PRU values<br /><br>in the normal BW/BMI group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine if the CYP2C19 genotype has additional effect on the platelet<br /><br>reactivity in the different treatment groups.<br /><br>- To assess the difference between PRU values in the high BW/BMI group during<br /><br>clopidogrel treatment and prasugrel treatment.<br /><br>- To assess possible confounders for high on-treatment platelet reactivity.<br /><br>- During the conduct of the study all clinical endpoints will be registered<br /><br>according to the definitions reported in the appendix. The following clinical<br /><br>endpoints will be reported: mortality (and cause of mortality), myocardial<br /><br>infarction, stent thrombosis, revascularization, stroke and bleedings. </p><br>