NCT05638867RecruitingPhase 4
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to compare short-term Triple Antithrombotic Therapy (DAPT + Rivaroxaban) followed by DAPT with standard DAPT in selected ACS patients with high ischemic risk. The main questions it aims to answer are: * Whether the intervention is effective in reducing ischemic events * Whether the intervention is safe from increasing bleeding events, especially severe or fatal ones Participants will be randomized to receive standard DAPT therapy for the entire study duration or low-dose rivaroxaban+DAPT for 3 months, followed by standard DAPT for the rest of the study duration. Patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3944 (estimated)
- First submitted
- 26 Nov 2022
- Start date
- 25 Nov 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT05638867
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 3944
- From 25 Nov 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of severe bleeding
- History of stroke/TIA
- Severe hepatic/renal insufficiency
Lab values
- Platelet level below 90 x10\^6
- Hemoglobin level is less than 11g/dL
Other
- Indicated for anticoagulation
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.