Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00743925
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2008-08-27
Brief Title:
FRANCIS-ACS Trial A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes
Sponsor:
Anthera Pharmaceuticals
Organization:
Anthera Pharmaceuticals
Study Overview
Official Title:
FRANCIS-ACS Trial A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2014-01
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:
FRANCIS-ACS
Brief Summary:
The objective of this study is to evaluate the safety and efficacy of A 002 when added to high dose atorvastatin in subjects with an acute coronary syndrome ACS
Detailed Description:
This is a double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS Subjects will be randomized to receive either A 002 500 mg once daily QD or placebo tablets in addition to 80 mg atorvastatin QD
Randomization must occur within 96 hours of hospital admission for the index ACS event or if already hospitalized within 96 hours of index event diagnosis Follow-up visits will occur at Weeks 2 4 8 12 16 20 and 24 post-randomization and monthly thereafter until study completion
All enrolled subjects will remain on treatment until all subjects have been treated for a minimum of 24 weeks or until the occurrence of a Major Adverse Cardiac Event MACE At that point all active subjects those who have not early withdrawn or those that have not already had a MACE will be brought in for a Final Study Visit Subjects who complete the Final Study Visit may be eligible to enroll in an open-label extension study for up to 2 years total study drug exposure
Randomization must occur within 96 hours of hospital admission for the index ACS event or if already hospitalized within 96 hours of index event diagnosis Follow-up visits will occur at Weeks 2 4 8 12 16 20 and 24 post-randomization and monthly thereafter until study completion
All enrolled subjects will remain on treatment until all subjects have been treated for a minimum of 24 weeks or until the occurrence of a Major Adverse Cardiac Event MACE At that point all active subjects those who have not early withdrawn or those that have not already had a MACE will be brought in for a Final Study Visit Subjects who complete the Final Study Visit may be eligible to enroll in an open-label extension study for up to 2 years total study drug exposure
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