Clinical trial NCT06103266: Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Official title: Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation
Coronary Artery Disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Primary ischemic endpoint
timeFrame: 6 months
measure: Primary bleeding endpoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: