DUAL Antithrombotic Therapy in Patients With AF and ACS

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Acute Coronary Syndromes
• Intervention / Treatment: Drug: Rivaroxaban 15 MG Oral Tablet; Drug: Ticagrelor 90 MG Oral Tablet; Drug: Clopidogrel 75 Mg Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4000
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Rivaroxaban 15 MG Oral Tablet; One 15 mg tablet once daily for up to twelve months; Other Names: Xarelto; Drug: Ticagrelor 90 MG Oral Tablet; One 90 mg tablet twice daily for up to twelve months; Other Names: P2Y12 antagonists
ACTIVE_COMPARATOR: 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	Drug: Rivaroxaban 15 MG Oral Tablet; One 15 mg tablet once daily for up to twelve months; Other Names: Xarelto; Drug: Clopidogrel 75 Mg Oral Tablet; One 75 mg tablet once daily for up to twelve months; Other Names: P2Y12 antagonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite endpoints of death and ischemic events	The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant bleeding	Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)	one year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Jun Jiang, PhD, Second Affiliated Hospital Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (ACTUAL): July 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Arrhythmias, Cardiac; Syndrome; Atrial Fibrillation; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Ticagrelor; Clopidogrel; Rivaroxaban
• Other Study ID Numbers: SAHZJU CT013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No