Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442949
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2007-03-02
Brief Title:
Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndrome ACS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention The ABOARD Study
Status:
COMPLETED
Status Verified Date:
2008-04
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:
ABOARD
Brief Summary:
Release of troponin evaluated by the peak of troponin during the hospital phaseBecause of its sensitivity and specificity as well as its widespread use in routine practice rise in troponin levels is the main assessment criteria of this study We plan to demonstrate a significantly altered distribution of the troponin release as evaluated by the peak of troponin for each patient during the hospitalization period from randomization to cardiologic unit discharge in the two arms of the trial
Detailed Description:
We propose to evaluate the optimal moment for catheterization in patients presenting with acute coronary syndromes by comparing rapid catheterization on the day of admission within 8 hours of admission with an average time close to 3 hours as in the rapid strategy arm of the ISAR-COOL trial with a slower approach where the examination is scheduled for the next working day 8 to 60 hours post admission with an average close to 24 hours Patients included will present with severe unstable angina defined as a TIMI score 3 All patients must present with an indication for catheterization and they will receive the same optimal pharmacological treatment including abciximab ReoPro when undergoing PCI and started just before the procedure as indicated in the label of the drug substitution by another drug of the class eptifibatide or tirofiban is not possible in the catheterization laboratory according to the labels of these two other drugs Randomization will evaluate only time to catheterization rapidly as soon as possible following admission within 8 hours of admission versus a delayed approach 8 to 60 hours following admission The goal of randomization is to determine the ideal time to catheterization while indications for catheterization pharmacological treatment and patient care remain constant This is a pragmatic study aiming to compare 2 different strategies in the management of ACS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None