Guiding NOAC therapy for patients with acute coronary syndrome after heart procedures
A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
This study is testing a new combination of heart medications to see if it can help people with acute coronary syndrome avoid serious heart problems without causing more bleeding than standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3944 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05638867 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of a short-term triple antithrombotic therapy, which includes DAPT and low-dose rivaroxaban, against standard DAPT in patients with acute coronary syndrome (ACS) who are at high ischemic risk. Participants will be randomly assigned to receive either the novel therapy for three months followed by standard DAPT or standard DAPT throughout the study. The trial will assess whether the new approach can reduce ischemic events without increasing the risk of severe bleeding. Patients will undergo five follow-up assessments during the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 diagnosed with acute coronary syndrome within 1-7 days after symptom stabilization, who have elevated D-dimer levels or a high PARIS risk score.
Not a fit: Patients with a history of severe bleeding, stroke, or those with significant hepatic or renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with acute coronary syndrome at high risk of ischemic events.
How similar studies have performed: Other studies have explored similar antithrombotic strategies, but this specific approach using the PARIS risk score and D-dimer levels is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jinqing Yuan, MD — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Jinqing Yuan, MD
- Email: dr_jinqingyuan@sina.com
- Phone: +86-10-68314466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.