Aspirin and clopidogrel versus aspirin alone for the prevention of blood clots following transcatheter aortic valve Implantation.

• Conditions: Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up.; MedDRA version: 17.0Level: LLTClassification code 10013118Term: Diseases of aortic valveSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001675-32-ES
• Lead Sponsor: IUCPQ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-22
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients undergoing a TAVI procedure with the Edwards valve.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

-Need for chronic anticoagulation treatment
-Major bleeding within the 3 months prior to the TAVI procedure
-Prior intracranial bleeding
-Drug-eluting stent implantation within the year prior to the TAVI procedure
-Allergy to clopidogrel and/or aspirin/acetylsalicylic acid

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified