Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066898
Status:
UNKNOWN
Last Update Posted:
2006-10-03
First Post:
2003-08-06
Brief Title:
ARISE - Aggressive Reduction of Inflammation Stops Events
Sponsor:
AtheroGenics
Organization:
AtheroGenics
Study Overview
Official Title:
Reduction of Vascular Inflammation and Coronary Atherosclerosis With AGI-1067 a V-Protectant Reduces Cardiovascular Events in Patients With Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety and efficacy of AGI-1067 as compared to placebo in the treatment of vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular events
Detailed Description:
This study will be a Phase III multi-center double-blind parallel group placebo-controlled trial involving approximately 260 study sites in the United States Canada South Africa and the United Kingdom It is expected that approximately 6600 subjects will be screened in order to randomize approximately 6000 subjects globally 3000 in each arm of the study Male or female subjects with coronary artery disease are eligible to participate if they meet all required inclusion and exclusion criteria Recruitment will be delayed for one month in subjects who have had a PCI Subjects who have a PCI planned at the time of screening or randomization will not be randomized until one month after this planned PCI has been conducted All subjects who successfully complete the screening phase and meet all required inclusion and exclusion criteria will be entered into the single-blind placebo Run-In phase of the study to establish compliance The placebo Run-In medication will be identical to the blinded study drug used in the randomized portion of the study After the completion of the two-week Run-In if compliance has been adequate study subjects will be randomized to receive AGI-1067 300 mg two 150 mg tablets daily with a meal or placebo approximately equal numbers of subjects per treatment group for a minimum of 12 months It is anticipated that subject accrual will occur over a period of approximately 24 months and that all subjects will be followed until at least 990 subjects have experienced a primary event Subjects will remain on drug therapy from randomization until the end of the study It is estimated that the first subject recruited will be exposed to blinded therapy for 30 to 36 months and the last subject will be exposed for a minimum of 6 to 12 months For the purposes of this study one month will be equal to 28 days The subject will be asked to return to the clinic at 1 month 3 months and every 3 months thereafter during the treatment phase All clinical laboratory procedures and electrocardiographic interpretations will be performed by central laboratories Over the study period subjects will be followed for the occurrence of major adverse cardiovascular events These potential endpoints will be adjudicated by an independent endpoint committee This committee will consist of cardiologists and other physician reviewers who will be blinded to the treatment For the purposes of safety the trial will be monitored by an independent Data Safety Monitoring Board This Board will consist of Cardiologists and at least one Statistician experienced in the conduct of clinical trials The Board will meet approximately every 6 months to review subject safety data
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