Atrial Fibrillation
Conditions
Keywords
safety, rivaroxaban, ticagrel, triple antithrombotic regimen, undergoing PCI
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.
Interventions
DRUGrivaroxaban and ticagrel therapy
Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.
DRUGtriple antithrombotic regimen with warfarin, asipirin and clopidogrel
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major or clinically relevant non-major bleeding | 12 months | 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
| Measure | Time frame |
|---|---|
| Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke | 12 months |
Countries
China
Contacts
Primary ContactYujie Zhou, MD
Backup ContactFei Gao, MD
Outcome results
None listed