Comparing effectiveness and safety of different blood thinners after transcatheter treatment for aortic stenosis

Phase 1

• Conditions: Patients with aortic stenosis undergoing transcatheter aortic valve implantation.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-001554-61-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Patients with aortic stenosis who are accepted for transcatheter aortic valve implantation by the heart team and are less than 80 years old at the time of the procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion Criteria

- Any clinical indication for either anticoagulation (atrial fibrillation, venous thrombosis) or antiplatelet drug (recent percutaneous coronary intervention, etc)
- Any contraindication for either anticoagulation or antiplatelet drugs
- Failure to provide signed consent
- Unable to start study medication within 72 hours
- Overt cognitive impairment

Study & Design

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