Integrated Biomarker And Imaging Study - 2
An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects With Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability
1 other identifier
interventional
336
11 countries
26
Brief Summary
IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2005
CompletedFirst Submitted
Initial submission to the registry
December 21, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2007
CompletedResults Posted
Study results publicly available
February 19, 2018
CompletedMarch 20, 2018
August 1, 2017
1.8 years
December 21, 2005
April 27, 2017
February 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52.
hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. Last Observation Carried Forward (LOCF) data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 52 were reported. The levels were analyzed using analysis of co-variance (ANCOVA), with Acute Coronary Syndrome (ACS) status, pooled country and treatment included as covariates.
Week 52
Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52.
The ROC grade III/IV strain spots per 10 millimetre (mm) within the ROI on intravascular ultrasound (IVUS) grey scale based palpography were assessed and change from Baseline at end of 52 was reported. Change from Baseline was calculated as the density of spots at the end of study minus the density of spots recorded at Baseline. If either value was considered missing then the change from Baseline value was missing for the participant. Between treatment group comparisons of change from Baseline were analyzed using ANCOVA adjusting for ACS status, pooled country, Baseline value, matched segment length and treatment. Adjusted means and associated standard errors for each treatment group were presented. The baseline value for each participant was defined as the last value prior to the first dose of study drug.
Baseline and Week 52
Secondary Outcomes (17)
Circulating Hs-CRP at the End of Week 26.
Week 26
Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52
Week 26 and Week 52
Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52
Baseline and Week 52
Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52
Baseline and Week 52
Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52
Baseline and Week 52
- +12 more secondary outcomes
Study Arms (4)
Subjects with ACS and evidence of MN:SB-480848
EXPERIMENTALEnrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks
Subjects with ACS and evidence of MN: placebo
PLACEBO COMPARATOREnrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks
Non-ACS and ACS subjects without evidence of MN: SB-480848
EXPERIMENTALEnrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks
Non-ACS and those ACS subjects without evidence of MN: placebo
PLACEBO COMPARATOREnrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks
Interventions
SB-480848 is available as enteric-coated, free-base micronized tablet
Placebo is available as enteric-coated, free-base micronized tablet
Eligibility Criteria
You may qualify if:
- Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization
- Suitable non-intervened coronary artery with IVUS
- Antiplatelet therapy
You may not qualify if:
- Clinical instability
- Previous CABG (Coronary Artery By-pass Graft) surgery
- Planned major surgery
- Recent stroke
- Abnormal QTc
- Renal or hepatic impairment
- Uncontrolled hypertension
- Use of corticosteroids
- Class III or IV heart failure
- Asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (26)
GSK Investigational Site
Vienna, A-1140, Austria
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Antwerp, 2020, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Aarhus N, DK-8200, Denmark
GSK Investigational Site
Besançon, 25000, France
GSK Investigational Site
Brest, 29609, France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89081, Germany
GSK Investigational Site
Munich, Bavaria, 80336, Germany
GSK Investigational Site
Bad Nauheim, Hesse, 61231, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795, Germany
GSK Investigational Site
Hamburg, 22527, Germany
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Enschede, 7511JX, Netherlands
GSK Investigational Site
Leeuwarden, 8934 AD, Netherlands
GSK Investigational Site
Rotterdam, 3015 GD, Netherlands
GSK Investigational Site
Rotterdam, 3075 EA, Netherlands
GSK Investigational Site
Bergen, 5053, Norway
GSK Investigational Site
Katowice, 40-635, Poland
GSK Investigational Site
Krakow, 31-501, Poland
GSK Investigational Site
Marid, 28040, Spain
GSK Investigational Site
Santander, 38008, Spain
GSK Investigational Site
Lucerne, 6000, Switzerland
Related Publications (1)
Serruys PW, Garcia-Garcia HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Botker HE, von Birgelen C, D'Amico D, Hutchinson T, Zambanini A, Mastik F, van Es GA, van der Steen AF, Vince DG, Ganz P, Hamm CW, Wijns W, Zalewski A; Integrated Biomarker and Imaging Study-2 Investigators. Effects of the direct lipoprotein-associated phospholipase A(2) inhibitor darapladib on human coronary atherosclerotic plaque. Circulation. 2008 Sep 9;118(11):1172-82. doi: 10.1161/CIRCULATIONAHA.108.771899. Epub 2008 Sep 1.
PMID: 18765397BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2005
First Posted
December 23, 2005
Study Start
November 10, 2005
Primary Completion
August 28, 2007
Study Completion
August 28, 2007
Last Updated
March 20, 2018
Results First Posted
February 19, 2018
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.