Atrial Fibrillation Clinical Trial
Official title:
An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation 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.
Status | Not yet recruiting |
Enrollment | 4000 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility |
Inclusion Criteria: 1. Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome 2. Planned use of antiplatelet agents for at least 12 months 3. Males and Females = 18 years of age 4. Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug Exclusion Criteria: 1. Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve) 2. Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min 3. Patients with a history of intracranial hemorrhage 4. Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event 5. Patients with known ongoing bleeding and patients with known coagulopathies 6. Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists 7. Have a history of stroke or Transient Ischemic Attack (TIA) 8. Have known significant liver disease or liver function test (LFT) abnormalities 9. Have any severe condition that would limit life expectancy to less than 12 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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