EUCTR2013-003492-35-DE进行中（未招募）1 期
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation with Dabigatran after Pulmonary Vein Isolation for Atrial Fibrillation - ODIn-AF Study
niversity of Bonn0 个研究点目标入组 630 人开始时间: 2015年3月17日最近更新:
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
- 630
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
- •- Written informed consent
- •- Patients undergoing circumferential antral PV ablation for non-valvular (mitral regurgitation less than moderate- severe; no relevant mitral ste-nosis with a mean pressure gradient >5mmHg) symptomatic, paroxys-mal AF or persistent AF (duration < 12 months) with risk factors resulting in a CHA2DS2VASc score =2, using a cooled tip RF-, laser- or cryo-balloon-catheter.
- •- CHA2DS2VASc score =2
- •Randomization criteria:
- •- Sinus rhythm (as assessed by 72h Holter ECG) following the 3 months blanking and 3 months observation period after first or second pulmonary vein ablation procedure
- •- No clinical evidence of recurrent AF after completing 3 months blanking and 3 months observation period as assessed by symptoms
- •- No other relevant contraindication for OAC assessed by randomization MRI of the brain
- •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 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •1.Severe mental retardation or psychiatrical disorder resulting in incapability to adequately understand nature, significance, implications and risks estimate the risks-and benefits of study parcipitation (i.e. bipolar disor-ders, severe depression, suicidal tendencies, among others) as judged by the local physician, ongoing, drug or alcohol addiction (> 8 drinks/week)
- •2.Pregnancy /breast feeding
- •3.Severely impaired renal function, GFR < 30 ml/min
- •4.Impaired liver function (ALT/AST transaminase count 3fold higher than normal values) or liver disease with reduced life expectancy <1 year
- •5.Valvular AF (less than moderate- severe; no relevant mitral stenosis with a mean pressure gradient >5mmHg)
- •6.Long standing persistent (>12 months) and permanent AF
- •7.NSTEMI/STEMI/implantated drug eluting stent with indication for dual antiplatelet therapy within 12 months before enrolment
- •8.History of complex left atrial ablation procedures. One previous PVI allowed.
- •9.Clinical indication for extended left atrial ablation procedures (lines, CFAE-, rotor-ablation)
- •10.History or presence of left atrial or ventricular thrombus
- •11.History of stroke / TIA independent from etiology
- •12.Acute major bleedings
- •13.Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
- •14.Need for concomitant anitcoagulation in addition to dabigatran
- •15.History of previous surgery resulting in contraindication for OAC
- •16.History of malignoma resulting in contraindication for OAC
- •17.Mechanical prosthetic heart valve or other indication for permanent OAC
- •18.Contraindication for MRI (i.e. metallical surgical implants unsuitable for MRI, cerebral port systems, wearing of magnetic or metallic objects that cannot be removed from the body (such as body piercing, implanted electrodes, contraceptive coil), inability to lie on the back for an extend-ed period of time, uncontrollable claustrophobia, hypersensitivity to noise etc.). Pacemaker and ICD-patients may be included at the dis-cretion of the local investigators/radiologists if MRI is warranted
- •19.Hypersensitivity against dabigatran or other ingredients of the medical product
- •20.Concomitant medication with dronedarone, ketoconazole, itraconazole, cyclosporine, tacrolimus or other interacting drugs as specified in the drug information
- •21.Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- •22.Females of childbearing potential, who are not using or not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- •23.Conditions which interfere with the study treatment at the discretion of the investigator
研究者
相似试验
已完成
不适用
Incidence of silent cerebral thromboembolism during catheter ablation of atrial fibrillatioI48.10DRKS00000782Cardoangiologisches Centrum Bethanien99
进行中（未招募）
1 期
Prevention of Stroke in Survivors of Brain Bleeding with Atrial FibrillatioEUCTR2018-002176-41-ITImperial College of Science, Technology and Medicine654
已完成
不适用
Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation * A Randomized Diffusion-Weighted MRI Study (CP-11134)severe headachedizzinessdifficulty in walkingloss of balance and coordinationblurred or double vision.Stroke: inability to move one or more limbs on one side of the bodyinability to understand or formulate speechinability to see one side of the visual fieldsudden10046973NL-OMON42354Claret Medical, Inc.24
已完成
2 期
Thrombolysis Or Anticoagulation for Cerebral venous ThrombosisCerebral venous thrombosiscerebral venous and sinus thrombosis1000796310014523NL-OMON34537Academisch Medisch Centrum38
已完成
4 期
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial FibrillationCardioembolic EventsOral AnticoagulationAtrial FibrillationNCT02067182Georg Nickenig200