Clinical Trials Logo
NCT number NCT01642134
Study type Interventional
Source Hospital de Meixoeiro
Contact Andres Iñiguez Romo, PHD,MD
Phone +0034986.811163
Status Recruiting
Phase Phase 4
Start date April 2013
Completion date April 2017
View Details

Clinical Trial Summary

The purpose of this study is to determine the incidence of major vascular events (ischemic or haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.

Clinical Trial Description

Transcatheter aortic valve implantation (TAVI) procedure using any of their vascular access is an option with proven benefit definitively for treatment of severe symptomatic aortic stenosis in patients considered unsuitable for conventional open heart surgery.

By avoiding the hemodynamic effects, cardiovascular and cerebral microembolic load of cardiopulmonary bypass circulation, it is assumed that the TAVI procedure is beneficial despite the risk of neurological complications. Currently antithrombotic therapy after the procedure is not standardized. International treatment guidelines recommends that post-operative patients with a conventional surgical aortic bioprosthesis maintain oral anticoagulation for 3 months after the procedure, unless otherwise noted for its continuation. Whereas some studies have postulated that in patients with aortic bioprostheses, dual antiplatelet therapy is as effective to prevent major cardiac and cerebrovascular events as oral anticoagulation, with a lower incidence of bleeding complications at 3 months of treatment, the investigators formulated the following hypothesis:

• There is a lower incidence of major cardiac and cerebrovascular events in patients with dual antiplatelet therapy compared to patients with oral anticoagulation for 3 months after implantation of an aortic bioprosthesis TAVI procedure.

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
See also
Status Clinical Trial Phase
 Not yet recruiting NCT02822144 - General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke Phase 3
 Not yet recruiting NCT02453373 - Helping Stroke Patients With ThermoSuit Cooling N/A
 Not yet recruiting NCT02688777 - A Novel Strategy to Decrease Fall Incidence Post-Stroke Phase 1/Phase 2
 Not yet recruiting NCT02230280 - My Stroke Team (MYST): Stroke App Pilot Study N/A
 Not yet recruiting NCT02828306 - Computer Based Algorithm for Patient Specific Implants for Cranioplasty in Patients With Skull Defects N/A
 Not yet recruiting NCT02667392 - Biofeedback to Increase Propulsion During Walking After Stroke Phase 1
 Recruiting NCT02762552 - Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke N/A
 Recruiting NCT02565199 - Premotor Cortex: A New Target for Stroke Motor Rehabilitation N/A
 Recruiting NCT02550717 - Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN) N/A
 Recruiting NCT02483676 - Ankle Robot to Reduce Foot-drop in Stroke Phase 2
 Recruiting NCT02625948 - Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign Phase 2
 Recruiting NCT02446587 - Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke N/A
 Recruiting NCT02533128 - Biomarkers, Blood Pressure, BIS: Risk Stratification/Management of Patients at Cardiac Risk in Major Noncardiac Surgery N/A
 Recruiting NCT02360488 - Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke Phase 1
 Recruiting NCT02550015 - High Intensity Interval Training After Stroke N/A
 Recruiting NCT02587585 - The Effect of Activity Feedback Enabled by Smart Watches During In-patient Stroke Rehabilitation Phase 2
 Recruiting NCT02793934 - The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation N/A
 Recruiting NCT02722720 - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral N/A
 Active, not recruiting NCT02702375 - Systematic Review and Meta-analysis of Food Sources of Sugars and Incident Cardiometabolic Diseases N/A
 Enrolling by invitation NCT02548234 - Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke N/A