Atrial FibrillationPhase 4IMPACT AF-PCINCT06103266
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
A Phase 4 study testing Rivaroxaban in people with Atrial Fibrillation and Coronary Artery Disease, run by J.P.S Henriques.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- Rivaroxaban
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban monotherapy | Experimental | 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 Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary ischemic endpoint
Composite of all-cause death, myocardial infarction, Academic Research Consortium defined definite stent trhombosis, or ischemic stroke
Measured: 6 months
Primary bleeding endpoint
International Society on Thrombosis and Haemostasis defined major bleeding or clinically relevant non-major bleeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J.P.S Henriques
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J.P.S Henriques, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103266
- Acronym
- IMPACT AF-PCI
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06103266
- Acronym / sponsor ID
- IMPACT AF-PCI
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- J.P.S HenriquesUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban monotherapy | Experimental | Drug: RivaroxabanOnce 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanOnce 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 monotherapy |
Primary outcome
Primary ischemic endpoint
Time frame: 6 months
Composite of all-cause death, myocardial infarction, Academic Research Consortium defined definite stent trhombosis, or ischemic stroke
Primary bleeding endpoint
Time frame: 6 months
International Society on Thrombosis and Haemostasis defined major bleeding or clinically relevant non-major bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban in people with Atrial Fibrillation and Coronary Artery Disease, run by J.P.S Henriques.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I. Tarik Küçük, MD (020 56 66405 ext. +31, i.t.kucuk@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary ischemic endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.