EUCTR2016-002353-38-DE进行中（未招募）1 期
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial - OCEA
Ottawa Heart Institute Research Corporation (OHIRC)0 个研究点目标入组 1,572 人开始时间: 2016年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,572
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1122
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •1.Patient does not meet all of the above listed inclusion criteria.
- •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.
- •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.
研究者
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