NCT05638867 NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
| NCT ID | NCT05638867 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,944 participants |
| Start Date | 2023-11-25 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,944 participants in total. It began in 2023-11-25 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jinqing Yuan, MD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT05638867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05638867 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05638867 currently recruiting?
Yes, NCT05638867 is actively recruiting participants. Contact the research team at dr_jinqingyuan@sina.com for enrollment information.
Where is the NCT05638867 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05638867 clinical trial?
NCT05638867 is sponsored by China National Center for Cardiovascular Diseases. The principal investigator is Jinqing Yuan, MD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 3,944 participants.