Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

— IMPACT AF-PCI  

Official title:

Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06103266
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: I. Tarik Küçük, MD
• Phone: 020 56 66405
• Email: i.t.kucuk[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
J.P.S Henriques

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary ischemic endpoint	Composite of all-cause death, myocardial infarction, Academic Research Consortium defined definite stent trhombosis, or ischemic stroke	6 months
Primary	Primary bleeding endpoint	International Society on Thrombosis and Haemostasis defined major bleeding or clinically relevant non-major bleeding	6 months