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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months) |
|
| Control Group | Other | Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin + Clopidogrel + Rivaroxaban | Drug | Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Death | 12 months | |
| Cardiac Death | 12 months | |
| Myocardial Infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | BARC 3,5 bleeding events | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinqing Yuan, MD | Contact | +86-10-68314466 | dr_jinqingyuan@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinqing Yuan, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40379336 | Derived | Jia S, Song Y, Yuan D, Wang P, Xu J, Chen Y, Zhang C, Zhao X, Yuan JQ. 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: study protocol for the PRIDE-ACS trial. BMJ Open. 2025 May 15;15(5):e090126. doi: 10.1136/bmjopen-2024-090126. |
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Open-label, Two-arm, Randomized Superiority Trial
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This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).
|
| Aspirin + Clopidogrel | Drug | Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily |
|
|
| 12 months |
| Stroke | 12 months |
| Ischemia-driven Revascularization | 12 months |
| Stent Thrombosis | 12 months |
| Systemic Embolism | 12 months |
| Net Adverse Clinical Events | Composite events including MACCE and bleeding | 12 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
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