Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Keywords
Novel Oral Anticoagulant, PARIS risk score, D-dimer, Acute Coronary Syndrome, Percutaneous Coronary Intervention
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.
Interventions
DRUGAspirin + Clopidogrel + Rivaroxaban
Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).
Intervention model description
Open-label, Two-arm, Randomized Superiority Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 12 months | Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Death | 12 months | — |
| Cardiac Death | 12 months | — |
| Myocardial Infarction | 12 months | — |
| Stroke | 12 months | — |
| Ischemia-driven Revascularization | 12 months | — |
| Stent Thrombosis | 12 months | — |
| Systemic Embolism | 12 months | — |
| Net Adverse Clinical Events | 12 months | Composite events including MACCE and bleeding |
Countries
China
Contacts
CONTACTJinqing Yuan, MD
PRINCIPAL_INVESTIGATORJinqing Yuan, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed