Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Device Related Thrombus (DRT) at 90 Days
研究概览
简要总结
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) to prevent device related thrombus.
详细描述
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.).
The drug will be initiated on the morning following device implantation, taken BID per package insert dosing and until follow-up 90-day post implant TEE. Aspirin monotherapy will be utilized in conjunction at 81 mg for up to 12 months, after which the patients will be exited from the study and further treatment decisions will be made by the following physician (see Schedule of Study Procedures at end of protocol). The objective of this trial is to evaluate safety and efficacy of a 90-day period of dabigatran etexilate following LAA closure to prevent device associated thrombus, while minimizing adverse bleeding by eliminating the need for clopidogrel.
This is a single arm pilot study with the option (pending collaboration with additional funding source) to expand to a full single arm non-inferiority trial design with 80% power to detect a 1.4% difference with the non-inferiority margin 1% in absolute rate of DAT (control rate 3.9%).
Prospective, non-randomized single arm study. Comparison will be made to historical controls based on published one year DAT rates from PROTECT-AF, PREVAIL clinical trials, and EWOLUTION, and ACP/Amulet registries.
Echocardiography (TEE) will be performed at 90 days (3 months, +/- 2-week window), and again at 1-year post implant (+/- 4 weeks). Selected images will be interpreted by echo lab at coordinating center in an anonymous fashion (patient data de-identified). Ideal imaging will incorporate 0, 45, 90 and 135 degree angled views on the device at follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female sex, age >18 years.
- •CHADS2 Vascular score of 3-9 and HAS BLED score 2 or higher meeting CMS coverage criteria for Watchman LAA closure device implantation.
- •Able to give informed consent.
- •Life expectancy of > 1year in the judgment of the implanting physician and shared decision-making physician.
排除标准
- •Unable to give informed consent
- •History of confirmed allergy to dabigatran etexilate
- •Active cerebral bleeding, or active non-cerebral bleeding requiring blood transfusions (any absolute contra-indications to anti-coagulation).
- •History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g. by surgery)
- •Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery)
- •Major bleeding episode (reduction in the haemoglobin level of at least 2g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) in one month prior to screening visit
- •Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI, including ESRD on hemodialysis or GFR < 15ml/min, or concomitant use of rifampin.
- •History of non-compliance, inability to follow-up.
- •Pre-menopausal women (last menstruation ≤ 1 year prior to screening) who are not surgically sterile.
- •Ischemic stroke or hemorrhagic stroke within 90 days of LAA placement.
- •Anatomy unsuitable for LAA closure (incomplete surgical LAA ligation without suitable anatomy for Watchman placement. LAA ostial measurements >31mm, or <17mm in all views).
- •Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation.
- •ASA allergy, or confirmed allergy to nickel.
- •Prior PFO or ASD closure device or prosthetic or mechanical heart valve.
- •Acute MI within 90 days.
- •Platelets <50,000 at time of Watchman LAAC implantation.
- •Active endocarditis.
- •Planning for endocardial catheter AF or left atrial ablation within 90 days of Watchman implantation.
研究组 & 干预措施
Treatment arm
Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)
干预措施: Dabigatran Etexilate Oral Capsule (Drug)
结局指标
主要结局
Device Related Thrombus (DRT) at 90 Days
时间窗: Baseline to 90 days
Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days
Device Related Thrombus (DRT) at 1 Year
时间窗: 90 days to 1 year
Transesophageal echocardiogram or CT angiography determined presence of DRT at 1 year post implant
次要结局
- Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events(Baseline to 90 days)
研究者
Arvindh Kanagasundram
Assistant Professor
Vanderbilt University Medical Center