Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04718025
Status:
RECRUITING
Last Update Posted:
2023-04-21
First Post:
2021-01-17
Brief Title:
Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome
Sponsor:
Collegium Medicum w Bydgoszczy
Organization:
Collegium Medicum w Bydgoszczy
Study Overview
Official Title:
Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome the Randomized Multicenter Double-blind ELECTRA RCT Study
Status:
RECRUITING
Status Verified Date:
2023-04
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:
ELECTRA-SIRIO
Brief Summary:
The ELECTRA-SIRIO 2 study is a randomized multicenter double-blind investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet strategies in patients with acute coronary syndrome ACS During the hospitalization due to ACS participants will be randomized in a 111 ratio into one of three arms low-dose ticagrelor with aspirin LDTA low-dose ticagrelor with placebo LDTP and standard-dose ticagrelor with aspirin SDTA the latter being the control arm Up to day 30 all enrolled patients will receive standard-dose ticagrelor 2x90mg aspirin 1x100mg Starting from day 31 LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg aspirin 1x100mg SDTA - continuation of previous treatment Starting from day 91 LDTP patients will receive low-dose ticagrelor 2x60mg placebo SDTA and LDTA - continuation of previous treatment The aim of the study is to evaluate the influence of ticagrelor maintenance dose reduction from 2x90mg to 2x60mg with or without continuation of aspirin versus dual antiplatelet therapy with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients
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?:
False
Is an FDA AA801 Violation?:
None