DUAL Antithrombotic Therapy in Patients With AF and ACS

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04023630
• Other study ID #: SAHZJU CT013
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jun Jiang, PhD
• Phone: 13588706891
• Email: hu888po[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Atrial Fibrillation
• Syndrome

Intervention

Drug:
• Rivaroxaban 15 MG Oral Tablet
One 15 mg tablet once daily for up to twelve months
• Clopidogrel 75 Mg Oral Tablet
One 75 mg tablet once daily for up to twelve months
• Ticagrelor 90 MG Oral Tablet
One 90 mg tablet twice daily for up to twelve months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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