Currently, there is minimal data on the combination of rivaroxaban and ticagrelor in patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI). Furthermore, there exists significant controversy among physicians in the use of oral anticoagulants in conjunction with antiplatelet therapy in this population. The present recommendation is triple therapy (aspirin + clopidogrel + warfarin), which has been related to major bleeding complications. Previous studies have shown that ticagrelor has been proven to be more effective in reducing the rate of death, new heart attacks, or strokes than the previously recommended drug, clopidogrel, and studies have shown that less bleeding occurs with rivaroxaban than with warfarin. Therefore, it would be ideal to investigate the two potent drugs, ticagrelor and rivaroxaban, in combination in order to gain insight in the management of these high-risk patients. The CAPITAL PCI AF study is a phase 3 Health Canada regulated interventional study involving the use of investigational drugs. It is a non-randomized, open-design study. The investigational team is studying the highly potent drug Ticagrelor, which is prescribed to participants receiving a stent placement, given in combination with Rivaroxaban, an oral anticoagulant recommended for patients with AF. The primary clinical endpoint is a safety outcome measuring bleeding complications in participants with AF treated within one year of the index PCI. The primary efficacy endpoint is measured by the clinical outcomes of death, stroke, non-central nervous system systemic embolism, myocardial infarction, and stent thrombosis within one year of the index PCI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Ticagrelor 90 mg twice daily
Rivaroxaban 15 mg once daily (10mg for patients with moderate renal impairment, creatinine clearance: 30-50 mL/min by the Cockcoft Gault method)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Composite of TIMI Bleeds
Composite of TIMI Major Bleed, Minor Bleed, and Bleeding requiring medical attention
Time frame: 12 months
The frequency of the individual components of the primary endpoint
Frequency of TIMI major, TIMI Minor, and TIMI bleeding requiring medical attention
Time frame: 12 months
The composite of multiple adverse cardiovascular events (MACE)
The composite of cardiovascular death and stroke events and its individual components
Time frame: 12 months
The frequency of stent thrombosis
Time frame: 12 months
All-cause mortality
Time frame: 12 months
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