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NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI

StatusRecruiting
PhasePhase 4
Started2023-11-25
View on ClinicalTrials.gov ↗

Amendment history

2026-08-09
Study Status, Eligibility v4
Eligibility criteriarevised
Inclusion Criteria: Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization, Aged 18-6575 years old, Elevated D-dimer levels (≥0.28 μg/ml) on admissi [...]
2024-01-14
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12→confirmed 2023-11-25
Eligibility criteria+2 characters
[...] ears old, Elevated D-dimer levels (≥0.28 μg/ml) on admission, or PARIS coronary thrombosis risk score ≥ 3 points, Received Pe [...]
Study sitesdetails revised at 1 of 1 site
2023-10-29
Study Status v2
Start date2023-06→2023-12
2023-06-06
Study Status, Study Design v1
PhasePhase 3→Phase 4
Start date2023-01→2023-06
2022-12-05
Original filing
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.
Trial Details
NCT Number NCT05638867
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Enrollment 3,944 participants
Start Date 2023-11-25
Primary Completion 2026-12 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-11