Guiding NOAC therapy for patients with acute coronary syndrome after heart procedures
Official title: 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
Run by China National Center for Cardiovascular Diseases · NCT05638867 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 3944 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | November 25, 2023 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT05638867 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have explored similar antithrombotic strategies, but this specific approach using the PARIS risk score and D-dimer levels is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization, * Aged 18-75 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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.