Clinical Trial: Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)

Brief Summary:

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).

Detailed Summary:

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.

Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: December 18, 2016
Date Started: March 2017
Date Completion: April 2018
Last Updated: December 27, 2016
Last Verified: December 2016