2024-518736-37-00招募中4 期
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 282
- 试验地点
- 19
- 主要终点
- The primary outcome is a composite of stroke, systemic embolism, and covert embolic stroke as defined by assessment of cerebral magnetic resonance imaging.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
- •Patient must be >18 years of age.
- •Patient must have non-valvular AF.
排除标准
- •Patient does not meet all of the above listed inclusion criteria.
- •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).
- •Patient has valvular atrial fibrillation [reference AHA guidelines].
- •Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
- •Patient had a severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
- •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.
- •Pregnancy or breastfeeding.
- •Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study.
- •Patients who are > 85 years of age.
- •Patients who are critically ill or who have a life expectancy <3 years.
- •Patients for whom the investigator believes that the trial is not in the interest of the patient.
- •Patient is unable or unwilling to provide informed consent.
- •Patient is included in another randomized clinical trial or a clinical trial requiring an insurance.
- •Patient has been on an investigational drug within 30 days of enrolment.
- •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.
- •Patient has creatinine clearance < 30 mL/min.
- •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).
- •Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent (such as allergy).
- •Patient has a contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
结局指标
主要结局
The primary outcome is a composite of stroke, systemic embolism, and covert embolic stroke as defined by assessment of cerebral magnetic resonance imaging.
The primary outcome is a composite of stroke, systemic embolism, and covert embolic stroke as defined by assessment of cerebral magnetic resonance imaging.
次要结局
- 2. Incidence of one or more covert MRI stroke(s) > 15 mm
- 1. Clinical, overt stroke
- 3. Composite of all major and minor bleeding
- 4. Major bleeding only
- 5. Minor bleeding only
- 6. Intracranial hemorrhage
- 7. Transient ischemic attack
- 8. All-cause mortality
- 9. Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events
- 10. Occurrence of non-primary endpoint MRI changes from baseline to final scan
- 11. Neuropsychological testing
- 12. Quality of life assessment
- 13. Cost utilization and cost effectiveness analysis
研究者
Sonya Jancar
Scientific
University Of Ottawa Heart Institute
研究点 (19)
Loading locations...
相似试验
已完成
4 期
Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug PhenprocoumonHip Replacement PostoperativeKnee Replacement PostoperativeAtrial FibrillationPulmonary EmbolismNCT00586287Cantonal Hospital of St. Gallen302
已完成
不适用
Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care UnitsCovid19NCT04829552William Beaumont Hospitals704
尚未招募
不适用
Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular ThrombosisEmbolism and ThrombosisAnticoagulationNCT06209892Chinese Academy of Medical Sciences, Fuwai Hospital220
已完成
3 期
Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin TherapyAnticoagulation in PregnancyNCT01758640Yasser Elnahas200
已完成
不适用
Better Outcomes for Anticoagulation Treatment Through Observation of Atrial RhythmNon-valvular Atrial FibrillationNCT03515083Saint Luke's Health System100