- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023630
DUAL Antithrombotic Therapy in Patients With AF and ACS
July 16, 2019 updated by: Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Jiang, PhD
- Phone Number: 13588706891
- Email: hu888po@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
- Planned use of antiplatelet agents for at least 12 months
- Males and Females ≥ 18 years of age
- 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:
- Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
- Patients with a history of intracranial hemorrhage
- Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- Patients with known ongoing bleeding and patients with known coagulopathies
- Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists
- Have a history of stroke or Transient Ischemic Attack (TIA)
- Have known significant liver disease or liver function test (LFT) abnormalities
- Have any severe condition that would limit life expectancy to less than 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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
|
One 15 mg tablet once daily for up to twelve months
Other Names:
One 90 mg tablet twice daily for up to twelve months
Other Names:
|
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
|
One 15 mg tablet once daily for up to twelve months
Other Names:
One 75 mg tablet once daily for up to twelve months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The composite endpoints of death and ischemic events
Time Frame: one year
|
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
Time Frame: one year
|
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
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jun Jiang, PhD, Second Affiliated Hospital ZheJiang University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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