IMPACT AF-PCI: Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Study Details
Study Description
Brief Summary
Rationale: Patients with atrial fibrillation who undergo percutaneous coronary intervention for coronary artery disease are treated with antiplatelet therapy on top of a non-vitamin K oral anticoagulant. Inevitably, this is associated with a higher risk of (major) bleeding. Given the reduction of ischemic risk with low-dose rivaroxaban and advances in stent properties, implantation techniques, and post-PCI management, it may be possible to treat atrial fibrillation patients after percutaneous coronary intervention with full-dose rivaroxaban and without antiplatelet therapy.
Objective: This study will serve as a pilot to investigate the feasibility and safety of rivaroxaban monotherapy in 50 patients with atrial fibrillation after percutaneous coronary intervention.
Study design: Single-centre, single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis Study population: Patients with atrial fibrillation and an indication for a non-vitamin K oral anticoagulant who undergo optimal percutaneous coronary intervention Intervention: Rivaroxaban 20 mg once daily or 15 mg once daily, in case of moderate-to-severe kidney dysfunction, for 6 or 12 months without antiplatelet therapy Main study endpoint: The primary ischemic endpoint is the composite of all-cause death, myocardial infarction, definite stent thrombosis, and ischemic stroke at 6 months after percutaneous coronary intervention. The primary bleeding endpoint is the composite of International Society on Thrombosis and Haemostasis defined major and clinically relevant non-major bleeding at 6 months after percutaneous coronary intevention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rivaroxaban monotherapy Once daily rivaroxaban 20 mg or 15 mg with reduced kidney function (eGFR 15 - 49 mmol/L) for 6 months in case of percutaneous coronary intervention for stable coronary artery disease or 12 months in case of percutaneous coronary intervention for acute coronary syndrome without concurrent antiplatelet therapy |
Drug: Rivaroxaban
Once daily rivaroxaban 20 mg or 15 mg with reduced kidney function (eGFR 15 - 49 mmol/L) for 6 months in case of percutaneous coronary intervention for stable coronary artery disease or 12 months in case of percutaneous coronary intervention for acute coronary syndrome without concurrent antiplatelet therapy
|
Outcome Measures
Primary Outcome Measures
- Primary ischemic endpoint [6 months]
Composite of all-cause death, myocardial infarction, Academic Research Consortium defined definite stent trhombosis, or ischemic stroke
- Primary bleeding endpoint [6 months]
International Society on Thrombosis and Haemostasis defined major bleeding or clinically relevant non-major bleeding
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years
-
Successful PCI
-
History of or newly diagnosed (<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC
-
Treatment with a loading dose of clopidogrel and aspirin prior to or during PCI
Exclusion Criteria:
-
Known allergy or contraindication for rivaroxaban
-
Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
-
Overwriting indication for DAPT (e.g. TIA/CVA or PAD)
-
Mechanical heart valve prosthesis
-
Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
-
Intracardiac thrombus or apical aneurysm requiring OAC
-
Kidney failure (eGFR <15)
-
Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
-
Active malignancy excluding non-melanoma skin cancer
-
Active bleeding on randomization
-
Severe anaemia requiring blood transfusion
-
Pregnancy or breast-feeding women
-
Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS
-
PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions
-
Participation in another trial with an investigational drug or device (i.e. stent)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- J.P.S Henriques