Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02750579
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2016-04-21
Brief Title:
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2018-04
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:
None
Brief Summary:
Percutaneous coronary intervention PCI is the cornerstone of the care of intermediate and high-risk non ST-elevation acute coronary syndromes NSTE ACS Revascularization reduces the rate of cardiovascular death and recurrent myocardial infarction in this clinical setting The recommendation regarding the timing of intervention in this clinical setting is derived from old trials and has a weak level of evidence In fact there are no conclusive randomized trials in the contemporary era providing guidance on the optimal timing of intervention In addition the optimal timing of this critical intervention has not been studied since the development of new P2Y12-ADP receptor antagonists and the controversy surrounding the use of pretreatment with a P2Y12-ADP receptor antagonist before intervention Early intervention in intermediate and high-risk non ST-elevation ACS is not well validated to date In addition the recent changes in the use of pretreatment with P2Y12-ADP receptor antagonists may impact on the potential benefit of an early intervention
Based on these evidences we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist an early PCI 2 hours would be superior to a delayed between 12 to 72 hours PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences
Based on these evidences we hypothesize that with the current protocols of care without pretreatment with a P2Y12-ADP receptor antagonist an early PCI 2 hours would be superior to a delayed between 12 to 72 hours PCI in the setting of intermediate or high-risk non-ST elevation acute coronary syndrome to prevent cardiovascular death and ischemic recurrences
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