EUCTR2016-002353-38-BE进行中（未招募）1 期
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial - OCEA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,284
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 1002
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 282
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
- •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
- •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
- •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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