Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-29 @ 1:53 AM
Study NCT ID:
NCT02735902
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2016-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVATAR
Brief 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)..
Detailed Description:
The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups:
1. Mortality (all causes).
2. Cardiovascular mortality.
3. The occurrence of myocardial infarction.
4. The occurrence of stroke.
5. The occurrence of valve thrombosis.
6. The occurrence of major bleeding (BARC ≥ 3).
7. The occurrence of minor bleeding (2 ≤ BARC \<3).
8. Treatment compliance.
1. Mortality (all causes).
2. Cardiovascular mortality.
3. The occurrence of myocardial infarction.
4. The occurrence of stroke.
5. The occurrence of valve thrombosis.
6. The occurrence of major bleeding (BARC ≥ 3).
7. The occurrence of minor bleeding (2 ≤ BARC \<3).
8. Treatment compliance.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-000352-98 | EUDRACT_NUMBER | None | View |