Safety and Effectiveness Trial of Apixaban Use in Association with Dual Antiplatelet Therapy in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Interventio

Phase 4

• Conditions: Patients with atrial fibrillation undergoing percutaneous coronary intervention

• Registration Number: JPRN-UMIN000015923
• Lead Sponsor: Cardiovascular Division, Faculty of Medicine, University of Tsukuba

Brief Summary

Primary endpoint all bleeding: 1 month vs 6 months; 11.8% vs 16.0% (Log-rank, P=0.34) Secondary endpoint Composite events (all-cause death, myocardial infarction, stroke, systemic embolization): 1 month vs 6 months; 9.8% vs 2.8% (Log-rank, P=0.053) Net Clinical Benefit (all-cause death, myocardial infarction, stroke, systemic embolization, bleeding with BARC type 3 or higher): 1 month vs 6 months; 10.8% vs 5.7% (Log-rank, P=0.22)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-01
• Study Completion: 2018-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who cannot tolerate antiplatelets and anticoagulants 2. Patients after mechanical valve replacement 3. Patients in whom a stent has been placed in the left main trunk 4. Patients in whom stents have been placed in a bifurcated lesion by the two stent technique 5. Patients complicated with decompensated heart failure or cardiogenic shock 6. Patients complicated with advanced chronic kidney disease (creatinine clearance <15 ml/min) 7. Patients with a past history of intracranial hemorrhage 8. Patients with a past history of stent thrombosis 9. Patients for whom surgery (cardiac and noncardiac surgery) is scheduled 10. Patients for whom pulmonary vein isolation is scheduled 11. Patients with active hemorrhage 12. Patients with active malignant tumor 13. Patients with pregnancy 14. Patients who are not expected to live 1 year or longer 15. Patients deemed to be inappropriate as the subjects of this study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any bleeding events: TIMI(Major/Minor), BARC, or blood transfusion

Secondary Outcome Measures

Name	Time	Method
1. Composite events of all-cause death, myocardial infarction, stroke, or systemic embolization 2. Net clinical benefit of all-cause death, myocardial infarction, stroke, or systemic embolization, and bleeding complications (BARC type 3 or higher) 3. Individual endpoints (1)All-cause death (2)Cardiovascular death (3)Non-cardiovascular death (4)Myocardial infarction (5)Unstable angina (6)Stroke (7)Systemic embolization (8)Stent thrombosis (9)Coronary revascularization (10)Surgery (11)CABG (12)Heart failure (13)Discontinuation of anticoagulant or antiplatelet treatment