Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05283356
Status:
RECRUITING
Last Update Posted:
2022-03-31
First Post:
2022-03-01
Brief Title:
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
Sponsor:
Fundacin Biomedica Galicia Sur
Organization:
Fundacin Biomedica Galicia Sur
Study Overview
Official Title:
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation Multicenter Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2022-03
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:
REAC-TAVI2
Brief Summary:
The optimal pharmacological therapy after transcatheter aortic valve implantation TAVI to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need Recently single antiplatelet therapy SAPT with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy However TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications Stroke is prevalent especially peri- and early post-TAVI 1-8 in the 1st year Although peri-TAVI myocardial infarction MI is rare 1-3 concomitant coronary artery disease CAD diabetes mellitus DM and peripheral vascular disease PVD is very frequent in the TAVI population affecting around 30-70 of patients In patients with CAD the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts
This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary cerebral and peripheral vascular territories compare to Aspirin The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI
This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary cerebral and peripheral vascular territories compare to Aspirin The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003927-13 | EUDRACT_NUMBER | None | None |