DUAL Antithrombotic Therapy in Patients With AF and ACS

• Status: Unknown status
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Clopidogrel; Rivaroxaban; Ticagrelor

Criteria

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