Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 75

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.

More Coronary Artery Disease trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment3944 (estimated)
SponsorChina National Center for Cardiovascular Diseases
Government
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedNovember 25, 2023
Main results expectedDecember 2026
Study endsJanuary 2027
Registry record updatedAugust 11, 2026
Trial IDNCT05638867 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.