Last updated: 11/07/2018 18:54:15
Integrated Biomarker And Imaging Study - 2
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean circulating high sensitivity C- Reactive Protein (hs-CRP) levels at Week 52.
Timeframe: 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.
Timeframe: Baseline and Week 52
Secondary outcomes:
Circulating hs-CRP at the end of week 26.
Timeframe: Week 26
Mean Lipoprotein Phospholipase A2 (Lp-PLA2) activity at the end of week 26 and week 52
Timeframe: Week 26 and Week 52
Change from Baseline in plaque volume as IVUS-Grey Scale Assessments at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Percent obstruction volume as IVUS-Grey Scale Assessments at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in necrotic core volume as intravenous Ultrasound-Virtual Histology (IVUS-VH) assessments at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in necrotic core as a percent of IVUS-VH plaque at the end of week 52.
Timeframe: Baseline and Week 52
Mean Interlukin 6 (IL-6) levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52
Timeframe: Week 26 and Week 52
Mean Intercellular Adhesion Molecule-1 (ICAM-1) levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52
Timeframe: Week 26 and Week 52
Mean Myeloperoxidase (MPO) levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52
Timeframe: Week 26 and Week 52
Mean sCD40L levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52
Timeframe: Week 26 and Week 52
Mean matrix metaloproteinases-9 (MMP-9) levels as circulating biomarkers associated with plaque instability at Week 26 and Week 52.
Timeframe: Week 26 and Week 52
Mean levels of Oxidised Phospholipids/ Apolipoprotein B100 (oxPL/apoB) ratio as target circulating biomarkers at the end of week 26 and week 52.
Timeframe: Week 26 and Week 52
Mean levels of oxidized non-esterified fatty acids (ox-NEFA) as target circulating biomarkers at the end of week 26 and week 52
Timeframe: Week 26 and Week 52
Change from Baseline in vessel volume and lumen volume as IVUS-Grey Scale Assessments at Week 52.
Timeframe: Baseline and Week 52
Change from Baseline in mean plaque area, mean vessel area, and mean lumen area as IVUS-Grey Scale Assessments at Week 52.
Timeframe: Baseline and Week 52
Change from Baseline in fibrous tissue volume and fibro-fatty volume as IVUS-VH assessments at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in fibrous tissue and fibro-fatty as a percent of IVUS-VH plaque as IVUS-VH assessments at Week 52
Timeframe: Baseline and Week 52
Interventions:
Drug: SB-480848
Drug: SB-480848 matching placebo
Enrollment:
336
Observational study model:
Not applicable
Primary completion date:
2007-28-08
Time perspective:
Not applicable
Clinical publications:
Serruys PW, García-García HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Bøtker HE, von Birgelen C, D’Amico Don, Hutchinson T, Zambanini A, Mastik F, van Es G-A, van der Steen AFW, Vince G, Ganz P, Hamm CW, Wijns W, Zalewski A for the Integrated Biomarker and Imaging Study-2 Investigators. Effects of the Direct Lipoprotein-Associated Phospholipase A2 Inhibitor Darapladib on Human Coronary Atherosclerotic Plaque. Circulation. 2008;118:1172-1182.
Serruys PW, García-García HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Bøtker HE, von Birgelen C, D’Amico Don, Hutchinson T, Zambanini A, Mastik F, van Es G-A, van der Steen AFW, Vince G, Ganz P, Hamm CW, Wijns W, Zalewski A for the Integrated Biomarker and Imaging Study-2 Investigators. Effects of the Direct Lipoprotein-Associated Phospholipase A2 Inhibitor Darapladib on Human Coronary Atherosclerotic Plaque. Circulation. 2008;118:1172-1182.
Medical condition
Atherosclerosis
Product
darapladib
Collaborators
Not applicable
Study date(s)
November 2005 to August 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization
- Suitable non-intervened coronary artery with IVUS
- Clinical instability
- Previous CABG (Coronary Artery By-pass Graft) surgery
Inclusion and exclusion criteria
Inclusion criteria:
- Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization
- Suitable non-intervened coronary artery with IVUS
- Antiplatelet therapy
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-28-08
Actual study completion date
2007-28-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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