Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-22
Brief Title:
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Sponsor:
JPS Henriques
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT AF-PCI
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None