CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 170 enrolled
Drug / intervention
Vitamin K antagonist or direct oral anticoagulant treatment +1 moredrug
Likely dose
Vitamin K antagonist or direct oral anticoagulant treatment 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02735902
NCT02735902Phase 4Completed
CompareCT.gov

Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

Centre Hospitalier Universitaire de Nīmes·interventional·Posted Apr 13, 2016·Updated Jul 24, 2024

In Brief

A Phase 4 clinical trial evaluating Vitamin K antagonist or direct oral anticoagulant treatment and Aspirin for Transcatheter Aortic Valve Replacement. Completed, enrolled 170 participants across 6 sites.

Detailed Summary

The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC 3 (other complications; Kappetein et al 2012)..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTranscatheter Aortic Valve Replacement
CountriesFrance
CollaboratorsMedtronic

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 13, 2016
Enrollment StartJun 1, 2017
Primary CompletionFeb 2, 2023
Study CompletionJan 19, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.2 years ago

Interventions

Vitamin K antagonist or direct oral anticoagulant treatmentdrug

The Vitamin K antagonist or direct oral anticoagulant treatment will be administered to obtain an International Normalized Ratio between 2 and 3 as recommended if the treatment is AVK. The Direct oral anticoagulant treatment : Apixaban 5 mg x2 or 2.5 mg X2, Edoxaban 30 ou 60 mg

Aspirindrug

Daily dose is between 75 mg and 100 mg. Allergic reactions to aspirin may be observed in rare cases. In case of suspicion of allergy, treatment with aspirin is stopped.