Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention (IMPACT AF-PCI)

J.P.S Henriques

Status and phase: Not yet enrolling; Phase 4

Conditions: Coronary Artery Disease; Atrial Fibrillation

Treatments: Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifier

NCT06103266

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Rivaroxaban monotherapy

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban