DUAL Antithrombotic Therapy in Patients With AF and ACS

NCT ID: NCT04023630

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-09-30

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.

Conditions

Atrial Fibrillation; Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rivaroxaban plus ticagrelor

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

Group Type: EXPERIMENTAL

Rivaroxaban 15 MG Oral Tablet

Intervention Type: DRUG

One 15 mg tablet once daily for up to twelve months

Ticagrelor 90 MG Oral Tablet

Intervention Type: DRUG

One 90 mg tablet twice daily for up to twelve months

rivaroxaban plus clopidogrel

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

Group Type: ACTIVE_COMPARATOR

Rivaroxaban 15 MG Oral Tablet

Intervention Type: DRUG

One 15 mg tablet once daily for up to twelve months

Clopidogrel 75 Mg Oral Tablet

Intervention Type: DRUG

One 75 mg tablet once daily for up to twelve months

Interventions

Rivaroxaban 15 MG Oral Tablet

One 15 mg tablet once daily for up to twelve months

Intervention Type: DRUG

Clopidogrel 75 Mg Oral Tablet

One 75 mg tablet once daily for up to twelve months

Intervention Type: DRUG

Ticagrelor 90 MG Oral Tablet

One 90 mg tablet twice daily for up to twelve months

Intervention Type: DRUG

Other Intervention Names

Xarelto; P2Y12 antagonists; P2Y12 antagonists

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jian'an Wang,MD,PhD

President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Jiang, PhD

Role: STUDY_DIRECTOR

Second Affiliated Hospital Zhejiang University School of Medicine

Central Contacts

Jun Jiang, PhD

Role: CONTACT

hu888po@126.com

13588706891

Other Identifiers

SAHZJU CT013

Identifier Type: -

Identifier Source: org_study_id