Body Weight Adjusted Clopidogrel Treatment in Patients With CORonary Artery Disease

Launched by ST. ANTONIUS HOSPITAL · Dec 9, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how adjusting the dose of a medication called clopidogrel can help patients with coronary artery disease, especially those with very low or very high body weight. Clopidogrel is used to prevent blood clots, but how well it works can depend on a person's weight. The trial will divide participants into three groups based on their body weight: low (under 60 kg), normal (60-100 kg), and high (over 100 kg). Depending on their weight, participants will receive different doses of clopidogrel to see which dosage provides the best results in reducing platelet activity, which is a measure of clotting.

To be eligible for the trial, participants must be at least 18 years old, have been on clopidogrel for at least one month, and must be able to provide consent. However, certain conditions will exclude some patients, such as those who have had recent heart issues or are pregnant. If you join the trial, you can expect to take clopidogrel for a set period and have your platelet activity monitored to see how well the treatment is working. This study aims to find a safer and more effective way to manage treatment for people with different body weights who have coronary artery disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients, male or female, ≥18 years of age
• • Patients treated for CCS 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:
• • 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