Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

Phase 3

• Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Intracranial Embolism
• Interventions: Drug: Postloading after TAVI; Drug: Preloading before TAVI

• Registration Number: NCT03001960
• Lead Sponsor: Charite University, Berlin, Germany

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 Description

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 Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-18
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Last Update Submitted: 2016-12-27
• Last Update Posted: 2016-12-28
• Study Start: 2017-03
• Primary Completion: 2018-03
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - POSTLoading AFTER TAVI	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
Group 1- PREloading BEFORE TAVI	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

Primary Outcome Measures

Name	Time	Method
Total volume of new cerebral lesions on MRI after TAVI versus Baseline	Total volume of new cerebral lesions on MRI, 24-72h after TAV versus Baseline

Secondary Outcome Measures

Name	Time	Method
New lesion volume of cerebral embolization in patients treated with ASS and Clopidogrel before versus after TAVI	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	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	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	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	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	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.	24-72 h after TAVI