Integrated Biomarker and Imaging Study – 2 (IBIS-2) - IBIS-2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: SB-480848 is under developement as a potential anti-atherosclerosis agent for reduction of major cardiovascular events in high risk patient populations.
Sponsor: GlaxoSmithKline Research & Development Limited
Enrollment: 300
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

October 4, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Signed written informed consent prior to beginning study\-related procedures (subject must understand the aims, investigational procedures and possible consequences of the study).
•2\. Male or female aged 18 to 80 years of age at screening. Female subjects of
•childbearing potential must be willing to follow contraceptive measures (described in
•Appendix 3 of study protocol).
•3\. Successful percutaneous coronary intervention (PCI) defined as placement of bare
•metal or drug eluting stent in the native coronary arteries
•Uncomplicated diagnostic cardiac catheterization in subjects in whom no PCI is
•Important: approximately \=50% of randomized subjects must present with ACS and
•evidence of myocardial necrosis (i.e., STEMI or NSTEMI). ACS is defined as a history
•of chest pain (or chest pain equivalent) lasting \= 20 minutes that occurred within 72 hours prior to the qualifying IVUS and the presence of elevated concentrations of cardiac biomarkers (troponins). Pre\-catheterization Troponin must be assessed at both central and local laboratories and determined to be \>99th percentile of the values for a reference control group to qualify as evidence of myocardial necrosis. The central laboratory Troponin I value will be used for the purpose of analyses.

•Clinical and laboratory exclusion criteria:
•1\. Evidence of clinical instability or new abnormal clinical laboratory findings post\-PCI
•or post cardiac catheterization but prior to randomization that in opinion of the
•investigator makes the subject unsuitable for the study.
•2\. History of CABG surgery.
•3\. Planned cardiac surgery (e.g., CABG, valve repair or replacement) or planned major
•non\-cardiac surgery within the study period.
•4\. Stroke or resuscitated cardiac arrest in the past 6 months.
•5\. QTc interval \>440msec (males) or \>450msec (females) at Screening
•6\. History of chronic viral hepatitis (including hepatitis B surface antigen or hepatitis C