Clinical trial NCT04023630: DUAL Antithrombotic Therapy in Patients With AF and ACS
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Acute Coronary Syndromes
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: The composite endpoints of death and ischemic events
timeFrame: one year
Secondary outcomes:
measure: Clinically significant bleeding
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Jun Jiang, PhD
role: STUDY_DIRECTOR
References: