Clinical Trials Logo

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT03001960
Study type Interventional
Source Charite University, Berlin, Germany
Status Not yet recruiting
Phase Phase 3
Start date March 2017
Completion date April 2018

See also
  Status Clinical Trial Phase
Completed NCT03186339 - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Terminated NCT02854319 - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Enrolling by invitation NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Recruiting NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity Phase 0
Active, not recruiting NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
Recruiting NCT01683474 - Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis N/A
Recruiting NCT01707927 - Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta. N/A
Active, not recruiting NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Terminated NCT01504737 - Rehabilitation in Aortic Stenosis Patients N/A