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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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
or
Uncomplicated diagnostic cardiac catheterization in subjects in whom no PCI is
planned.
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.
4. Baseline IVUS of the non-intervened coronary arterial segment recorded according
to protocol-mandated criteria that contains a lesion with less than 50% stenosis by
visual inspection on angiography (refer to IBIS-2 Study Manual: – Imaging Procedures and Measurements [Core Imaging Laboratory, 2005])
5. Must be receiving at least one oral antiplatelet agent (e.g., aspirin, clopidogrel) at
time of randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
antibody) or other chronic hepatic disorder. ALT or AST >2.5 x upper limit of normal or alkaline phosphatase or total bilirubin >1.5 x upper limit of normal at Screening.
7. Renal impairment with serum creatinine >2.0 mg/dL (177umol/L) or calculated creatinine clearance <40 mL/min/1.73 m2 at Screening (based on MDRD Study equation [Levey, 1999]), or history of kidney transplant, or history of contrast nephropathy.
8. Current inadequately controlled hypertension (blood pressure >160 mmHg systolic
and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication.
9. Recent use (within < 1 month) or currently receiving transdermal, oral, inhaled, or
injectable corticosteroids.
10. Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screen.
11. History of severe heart failure defined as NYHA class III or IV or known severe left ventricular (LV) dysfunction (ejection fraction [EF]<30%) regardless of symptomatic status.
12. History of adult asthma manifested by bronchospasm in the past 6 months, or
currently taking regular anti-asthmatic medication(s).
13. History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months.
14. History of malignancy within the past 5 years, other than non-melanoma skin cancer.
15. Current life-threatening condition other than vascular disease (e.g., very severe
chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent
a subject from completing the study.
16. Alcohol or drug abuse within the past 6 months.
17. Currently receiving oral or injectable potent CYP3A4 inhibitor(s). Subjects should be instructed to refrain from consumption of > 240mL daily of grapefruit-juice, which may inhibit CYP3A4.
18. Previous exposure to SB-480848.
19. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
20. Pregnancy (defined as a positive pregnancy test by serum ß-HCG) or lactation at
Screening.
21. Any subject the investigator deems unsuitable for the study (e.g., due to medical
reasons, laboratory abnormalities, expected study medication noncompliance, or unwillingness or inability to comply with all study-related procedures).
Anatomical exclusion criter

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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