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The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
EU CTIS ID: 2024-518736-37-00
What this study is testing
This phase 4 trial investigates whether a strategy of ongoing, long-term oral anticoagulation is superior to a strategy of antiplatelet therapy (ASA) alone in reducing the incidence of cerebral embolic events in moderate risk patients post-successful catheter ablation for atrial fibrillation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patient must be at least one year post-successful catheter ablation(s) for atrial fibrillation without evidence of any clinically apparent arrhythmia recurrence defined as all of the following: No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent) from 2-6 months after the last ablation, AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after 6 months after the last ablation AND no AF/AT/AFL on at least 24 hour Holter and ECG 2 months before enrolment in the study. The Holter/ECG within 2 months of enrolment may also serve as the Holter performed 6 months or later after the last ablation - see section 2.3.1 for details
- 2. Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients in whom female sex or vascular disease are their sole risk factor may not be enrolled.
- 3. Patient must be >18 years of age.
- 4. Patient must have non-valvular AF.
You likely can't join if
- 1. Patient does not meet all of the above listed inclusion criteria.
- 10. Patients with a contraindication to implantation of an implantable loop recorder if the patient opts for loop recorder as part of the study (such as limited immunocompetence or a wound healing disorder).
- 11. Patient has valvular atrial fibrillation [reference AHA guidelines].
- 12. Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
- 13. Patient had a severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
- 14. Patient with special risk factors for stroke unrelated to AF, specifically known thrombophilia/ hypercoagulability, uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
See the full eligibility criteria
Who can join
- 1. Patient must be at least one year post-successful catheter ablation(s) for atrial fibrillation without evidence of any clinically apparent arrhythmia recurrence defined as all of the following: No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent) from 2-6 months after the last ablation, AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after 6 months after the last ablation AND no AF/AT/AFL on at least 24 hour Holter and ECG 2 months before enrolment in the study. The Holter/ECG within 2 months of enrolment may also serve as the Holter performed 6 months or later after the last ablation - see section 2.3.1 for details
- 2. Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients in whom female sex or vascular disease are their sole risk factor may not be enrolled.
- 3. Patient must be >18 years of age.
- 4. Patient must have non-valvular AF.
What rules you out
- 1. Patient does not meet all of the above listed inclusion criteria.
- 10. Patients with a contraindication to implantation of an implantable loop recorder if the patient opts for loop recorder as part of the study (such as limited immunocompetence or a wound healing disorder).
- 11. Patient has valvular atrial fibrillation [reference AHA guidelines].
- 12. Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
- 13. Patient had a severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
- 14. Patient with special risk factors for stroke unrelated to AF, specifically known thrombophilia/ hypercoagulability, uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
- 15. Pregnancy or breastfeeding.
- 16. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study.
- 17. Patients who are > 85 years of age.
- 18. Patients who are critically ill or who have a life expectancy <3 years.
- 19. Patients for whom the investigator believes that the trial is not in the interest of the patient.
- 2. Patient is unable or unwilling to provide informed consent.
- 3. Patient is included in another randomized clinical trial or a clinical trial requiring an insurance.
- 4. Patient has been on an investigational drug within 30 days of enrolment.
- 5. Patient has been on strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days of enrolment.
- 6. Patient has creatinine clearance < 30 mL/min.
- 7. Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding history, fibrinolysis within 48 hours of enrollment).
- 8. Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent (such as allergy).
- 9. Patient has a contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Israel
- China
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Israel; China; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.