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To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (PCI).
This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (warfarin, clopigogrel and aspirin) in patients, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and concomitant coronary artery disease undergoing percutaneous coronary intervention (PCI). A target of 420 participants will be randomized into the study, with approximately 210 participants in each treatment strategy group. Primary comparisons will be made of the rates of major and clinically relevant bleeding, assessed by the modified International Society of Thrombosis and Haemostasis (ISTH) classification. The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual antithrombotic therapy (DAT) | Experimental | Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d. |
|
| Triple antithrombotic therapy (TAT) | Active Comparator | Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rivaroxaban and ticagrel therapy | Drug | Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Major or clinically relevant non-major bleeding | Major bleeding was assessed by the International Society of Thrombosis and Hemostasis (ISTH) definition. It included bleeding that was fatal, occurred in a critical location (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, intramuscular with compartment syndrome, or pericardial), or was associated with a fall in hemoglobin of 2 g/dL or a transfusion of 2 units of packed red blood cells. Clinically relevant non-major bleeding was defined as bleeding that required medical or surgical intervention. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujie Zhou, MD | Contact | 86 18610323937 | yjzhou.az@gmail.com | |
| Fei Gao, MD | Contact | 1-347-257-4916 | fgaomd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yujie Zhou, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26003433 | Derived | Gao F, Shen H, Wang ZJ, Yang SW, Liu XL, Zhou YJ. Rationale and design of the RT-AF study: Combination of rivaroxaban and ticagrelor in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention. Contemp Clin Trials. 2015 Jul;43:129-32. doi: 10.1016/j.cct.2015.05.012. Epub 2015 May 21. |
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| triple antithrombotic regimen with warfarin, asipirin and clopidogrel | Drug |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
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