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DUAL Antithrombotic Therapy in Patients With AF and ACS

Zhejiang University logo

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)

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

Trial contacts and locations

0

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Central trial contact

Jun Jiang, PhD

Data sourced from clinicaltrials.gov

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