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The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rivaroxaban plus ticagrelor | Experimental | rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months |
|
| rivaroxaban plus clopidogrel | Active Comparator | rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 15 MG Oral Tablet | Drug | One 15 mg tablet once daily for up to twelve months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The composite endpoints of death and ischemic events | The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization ) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant bleeding | Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA) | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Jiang, PhD | Contact | 13588706891 | hu888po@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Jiang, PhD | Second Affiliated Hospital Zhejiang University School of Medicine | Study Director |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013607 | Tablets |
| D000077144 | Clopidogrel |
| D058921 | Purinergic P2Y Receptor Antagonists |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Clopidogrel 75 Mg Oral Tablet | Drug | One 75 mg tablet once daily for up to twelve months |
|
|
| Ticagrelor 90 MG Oral Tablet | Drug | One 90 mg tablet twice daily for up to twelve months |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058919 | Purinergic P2 Receptor Antagonists |
| D058914 | Purinergic Antagonists |
| D058905 | Purinergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |