Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- Total volume of new cerebral lesions on MRI after TAVI versus Baseline
研究概览
简要总结
TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen.
The study evaluates the effect of dual antiplatelet pretreatment on periinterventional embolic cerebral lesions and bleeding complications in patients undergoing transfemoral aortic valve implantation (TF-TAVI).
详细描述
Patients undergoing TAVI bear a high risk of ischaemic stroke, which is an independent predictor of mortality1. Dual antiplatelet therapy (DAPT) is recommended by current guidelines without clear specifications on the time of initiation of treatment due to a lack of data. While some centers initiate DAPT with aspirin and clopidogrel prior to TAVI to reduce the rate of periinterventional embolic events, others start these medications after the procedure.Data on antithrombotic therapy during TAVI are scarce and no randomized evaluation has been performed to demonstrate what the best strategy is during the procedure.
Therefore, the objective of this clinical trial is to assess the efficacy of pre- versus postoperative dual antiplatelet loading with Aspirin and Clopidogrel on volume of periinterventional cerebral ischemic lesions as quantified by diffusion weight MRI (DW-MRI) and neurocognitive function in patients undergoing transfemoral aortic valve replacement. The statistical trial design assumes superiority of preloading with DAPT regarding the primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1- PREloading BEFORE TAVI
- Aspirin 100 mg loading orally 6-12 hours before TAVI and
- Clopidogrel 600mg loading 6-12 before TAVI followed by maintenance dose of 100mg aspirin and 75mg clopidogrel per day
干预措施: Preloading before TAVI (Drug)
Group 2 - POSTLoading AFTER TAVI
- Aspirin 100 mg loading orally 6-12 hours after TAVI and
- Clopidogrel 600mg loading 6-12 hours after TAVI followed by maintenance dose of 100mg aspirin and 75mg clopidogrel per day
干预措施: Postloading after TAVI (Drug)
结局指标
主要结局
Total volume of new cerebral lesions on MRI after TAVI versus Baseline
时间窗: Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline
次要结局
- New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI(24-72h post TAVI versus baseline)
- location of new cerebral lesions early AFTER TAVI(24-72h after TAVI)
- extent of new cerebral lesions early AFTER TAVI(24-72h after TAVI)
- Assessment of different neurocognitive tests before and after TAVI procedure(24-72 h after TAVI)
- Extent of clinically apparent non-cerebral emboli after TAVI(24-72 h after TAVI)
- localization of clinically apparent non-cerebral emboli after TAVI(24-72 h after TAVI)
- Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score.(24-72 h after TAVI)
研究者
Alexander Lauten
Prof. Dr. med.
Charite University, Berlin, Germany