Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rivaroxaban and ticagrel therapy
triple antithrombotic regimen with warfarin, asipirin and clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring safety, rivaroxaban, ticagrel, triple antithrombotic regimen, undergoing PCI
Eligibility Criteria
Inclusion Criteria:
- a long-term indication for oral anticoagulation treatment (until at least 1 year after the study)
- a severe coronary lesion (at least 75% stenosis on angiography or fractional flow reserve lower than 0•80) with indication for PCI
- age 18-80 years
Exclusion Criteria:
- history of intracranial bleeding;
- cardiogenic shock;
- contra indication to use of antiplatelet or anticoagulation drugs;
- peptic ulcer in the previous 6 months;
- thrombo cytopenia (platelet concentration lower than 50~10⁹/L);
- major bleeding (according to the Thrombolysis in Myocardial Infarction [TIMI] criteria) in the past 12 months; and
- pregnancy.
Sites / Locations
- Beijing Anzhen Hospital,Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dual antithrombotic therapy (DAT)
Triple antithrombotic therapy (TAT)
Arm Description
Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.
Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5).
Outcomes
Primary Outcome Measures
Major or clinically relevant non-major bleeding
Major bleeding was assessed by the International Society of Thrombosis and Hemostasis (ISTH) definition. It included bleeding that was fatal, occurred in a critical location (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, intramuscular with compartment syndrome, or pericardial), or was associated with a fall in hemoglobin of 2 g/dL or a transfusion of 2 units of packed red blood cells. Clinically relevant non-major bleeding was defined as bleeding that required medical or surgical intervention.
Secondary Outcome Measures
Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke
Full Information
NCT ID
NCT02334254
First Posted
January 6, 2015
Last Updated
January 7, 2015
Sponsor
Beijing Anzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02334254
Brief Title
Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Official Title
Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (PCI).
Detailed Description
This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (warfarin, clopigogrel and aspirin) in patients, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and concomitant coronary artery disease undergoing percutaneous coronary intervention (PCI). A target of 420 participants will be randomized into the study, with approximately 210 participants in each treatment strategy group. Primary comparisons will be made of the rates of major and clinically relevant bleeding, assessed by the modified International Society of Thrombosis and Haemostasis (ISTH) classification. The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
safety, rivaroxaban, ticagrel, triple antithrombotic regimen, undergoing PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual antithrombotic therapy (DAT)
Arm Type
Experimental
Arm Description
Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.
Arm Title
Triple antithrombotic therapy (TAT)
Arm Type
Active Comparator
Arm Description
Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5).
Intervention Type
Drug
Intervention Name(s)
rivaroxaban and ticagrel therapy
Intervention Description
Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.
Intervention Type
Drug
Intervention Name(s)
triple antithrombotic regimen with warfarin, asipirin and clopidogrel
Primary Outcome Measure Information:
Title
Major or clinically relevant non-major bleeding
Description
Major bleeding was assessed by the International Society of Thrombosis and Hemostasis (ISTH) definition. It included bleeding that was fatal, occurred in a critical location (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, intramuscular with compartment syndrome, or pericardial), or was associated with a fall in hemoglobin of 2 g/dL or a transfusion of 2 units of packed red blood cells. Clinically relevant non-major bleeding was defined as bleeding that required medical or surgical intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a long-term indication for oral anticoagulation treatment (until at least 1 year after the study)
a severe coronary lesion (at least 75% stenosis on angiography or fractional flow reserve lower than 0•80) with indication for PCI
age 18-80 years
Exclusion Criteria:
history of intracranial bleeding;
cardiogenic shock;
contra indication to use of antiplatelet or anticoagulation drugs;
peptic ulcer in the previous 6 months;
thrombo cytopenia (platelet concentration lower than 50~10⁹/L);
major bleeding (according to the Thrombolysis in Myocardial Infarction [TIMI] criteria) in the past 12 months; and
pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujie Zhou, MD
Phone
86 18610323937
Email
yjzhou.az@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Gao, MD
Phone
1-347-257-4916
Email
fgaomd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Gao, MD
Phone
1-347-257-4916
Email
fgaomd@163.com
First Name & Middle Initial & Last Name & Degree
Hua Shen, MD
Phone
86 13718667442
Email
shenhua0402@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26003433
Citation
Gao F, Shen H, Wang ZJ, Yang SW, Liu XL, Zhou YJ. Rationale and design of the RT-AF study: Combination of rivaroxaban and ticagrelor in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention. Contemp Clin Trials. 2015 Jul;43:129-32. doi: 10.1016/j.cct.2015.05.012. Epub 2015 May 21.
Results Reference
derived
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Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
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