DUAL Antithrombotic Therapy in Patients With AF and ACS

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation; Acute Coronary Syndromes

Treatments: Drug: Rivaroxaban 15 MG Oral Tablet; Drug: Clopidogrel 75 Mg Oral Tablet; Drug: Ticagrelor 90 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04023630

SAHZJU CT013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,000 participants in 2 patient groups

rivaroxaban plus ticagrelor

Experimental group

Description:

rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months

Treatment:

Drug: Ticagrelor 90 MG Oral Tablet

Drug: Rivaroxaban 15 MG Oral Tablet

rivaroxaban plus clopidogrel

Active Comparator group

Description:

rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months

Treatment:

Drug: Clopidogrel 75 Mg Oral Tablet

Drug: Rivaroxaban 15 MG Oral Tablet