Antiplatelet therapy for patients undergoing transcatheter aortic valve implantatio

Phase 1

• Conditions: Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.; MedDRA version: 19.1Level: PTClassification code 10002906Term: Aortic stenosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003125-28-GB
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Cohort A
1.Patient has provided written informed consent.

Cohort B
1.Need for long-term oral anticoagulation;
2.Patient has provided written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

Cohort A
1.Need for long-term oral anticoagulation.
2.Drug-eluting stent implantation within 3 months prior to TAVI procedure.
3.Bare-metal stent implantation within 1 month prior to TAVI procedure.
4.Allergy or intolerance or contraindication to aspirin or clopidogrel.

Cohort B
1.Drug-eluting stent implantation within 3 months prior to TAVI procedure.
2.Bare-metal stent implantation within 1 month prior to TAVI procedure.
3.Use of non-vitamin K oral anticoagulation (NOAC).
4.Allergy or intolerance or contraindication to OAC or clopidogrel.

Study & Design

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