Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI (DAPT-TAVI)
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|ClinicalTrials.gov Identifier: NCT03001960|
Recruitment Status : Unknown
Verified December 2016 by Alexander Lauten, Charite University, Berlin, Germany.
Recruitment status was: Not yet recruiting
First Posted : December 23, 2016
Last Update Posted : December 28, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Intracranial Embolism||Drug: Preloading before TAVI Drug: Postloading after TAVI||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)|
|Study Start Date :||March 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: Group 1- PREloading BEFORE TAVI
Drug: Preloading before TAVI
Preloading with Aspirin and Clopidogrel before TAVI
Other Name: ASS, Plavix
Experimental: Group 2 - POSTLoading AFTER TAVI
Drug: Postloading after TAVI
Postloading with Aspirin and Clopidogrel after TAVI
Other Name: ASS, Plavix
- Total volume of new cerebral lesions on MRI after TAVI versus Baseline [ Time Frame: Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline ]
- New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI [ Time Frame: 24-72h post TAVI versus baseline ]Total new lesion volume is defined as the sum volume of all new cerebral ischemic lesions on the post-procedural MRI relative to the pre-TAVR cerebral MRI scan (on diffusion weighted and FLAIR MRI images).
- location of new cerebral lesions early AFTER TAVI [ Time Frame: 24-72h after TAVI ]To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan
- extent of new cerebral lesions early AFTER TAVI [ Time Frame: 24-72h after TAVI ]To evaluate cerebral embolisation, which is not procedure related, cerebral embolisation on MRI will be before TAVI versus the post-TAVI MRI scan
- Assessment of different neurocognitive tests before and after TAVI procedure [ Time Frame: 24-72 h after TAVI ]To evaluate neurologic function with a battery of neurocognitive tests and to correlate these findings to cerebral MRI scans
- Extent of clinically apparent non-cerebral emboli after TAVI [ Time Frame: 24-72 h after TAVI ]To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)
- localization of clinically apparent non-cerebral emboli after TAVI [ Time Frame: 24-72 h after TAVI ]To describe extent and localization of non-cerebral embolisation (e.g. pulmonary embolism, limb ischaemia...)
- Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. [ Time Frame: 24-72 h after TAVI ]