NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to prevent serious heart issues in patients who have had a recent heart attack or heart-related problem, known as Acute Coronary Syndrome (ACS), and have undergone a procedure called Percutaneous Coronary Intervention (PCI). The researchers want to find out if a combination treatment that includes a blood thinner called rivaroxaban along with standard dual antiplatelet therapy (DAPT) can help reduce the chances of heart problems without causing more bleeding issues. Participants will be divided into two groups: one will receive the new combination treatment for the first three months, followed by standard care, while the other group will receive only the standard treatment throughout the study.

To be eligible for this trial, participants need to be between 18 and 65 years old, have recently stabilized from an ACS event, and have certain risk factors, like high D-dimer levels or a specific risk score. Participants will need to visit the clinic or have phone check-ins five times during the study to monitor their progress. This trial is currently looking for volunteers, and it’s important to note that people with certain health issues, like a history of severe bleeding or certain blood conditions, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,
• • Aged 18-65 years old,
• • Elevated D-dimer levels (≥0.28 μg/ml) on admission or PARIS coronary thrombosis risk score ≥ 3 points,
• • Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,
• • Indicated for dual antiplatelet medication
• Exclusion Criteria:
• • Platelet level below 90 x10\^6
• • Hemoglobin level is less than 11g/dL
• • History of severe bleeding
• • History of stroke/TIA
• • Severe hepatic/renal insufficiency
• • Indicated for anticoagulation

Trial Officials