A Clinical Outcomes Study of Darapladib versus Placebo inSubjects with Chronic Coronary Heart Disease to Compare theIncidence of Major Adverse Cardiovascular Events (MACE). - STABILITY

• Conditions: coronary heart disease; MedDRA version: 9.1Level: LLTClassification code 10011099Term: Coronary disease

• Registration Number: EUCTR2008-005575-96-IT
• Lead Sponsor: GlaxoSmithKline Research & Development, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-11
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 19000

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 at least 18 years, inclusive, at screening. Female subjects must
be post-menopausal or using a highly effective method for avoidance of pregnancy
4 The decision to include or exclude women of guidelines or contraindicated in the opinion of the investigator.5
4. Chronic CHD documented by at least one of the following:
a. prior MI (>1 month prior to randomization).6
b. prior coronary revascularization procedure [percutaneous coronary intervention
(PCI) > 1 month prior to randomization or coronary artery bypass graft (CABG)
>3 months prior to randomization].7
c. multivessel CHD involving major epicardial coronary arteries confirmed by
coronary angiography at any time (without revascularization).8
AND
5. At least one of the following additional predictors of CV risk:
a. age ≥60 years at randomization.
b. diabetes mellitus requiring pharmacotherapy.
c. HDL-C <40 mg/dL (1.03 mmol/L).
d. smoker (defined as at least 5 cigarettes per day on average) or a previous
smoker (defined as at least 5 cigarettes per day on average when smoking) who
discontinued within the past 3 months.
e. significant renal dysfunction (defin
childbearing potential may be made at the discretion of the investigator in
accordance with local practice in relation to adequate contraception.
3. Current treatment with statin therapy
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

1. Planned coronary revascularization (PCI or CABG) or any other major surgical
procedure.
2. Current liver disease, known hepatic or biliary abnormalities (with the exception of
Gilbert?s syndrome or asymptomatic gallstones) or evidence of abnormal liver
function tests [total bilirubin or alkaline phosphatase >1.5 x upper limit of normal
(ULN); or ALT or AST >2.5 x ULN or other hepatic abnormalities that in the
opinion of the Investigator would preclude the subject from participation in the
study.
3. Severe renal impairment (eGFR13 <30 mL/min/1.73 m2) or history of nephrectomy
or kidney transplant (regardless of renal function).
4. Current severe heart failure (New York Heart Association class III or IV).
5. Poorly controlled hypertension despite lifestyle modifications and
pharmacotherapy
6. Any life-threatening condition with life expectancy <2 years, other than vascular disease, that might prevent the subject from completing the study (e.g., very severe
chronic airways disease, known human immunodeficiency virus [HIV] positive, or
cancer in the past five years other than non-melanoma skin cancer).
7. Severe asthma that is poorly controlled on pharmacotherapy.
8. Positive pregnancy test (all female subjects of childbearing potential must have a
urine &#946;-human chorionic gonadotropin [hCG] pregnancy test performed at Screening
and/or within 7 days prior to randomization) or is known to be pregnant or lactating.
History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions (Refer to
9. Clinical criteria for diagnosing anaphylaxis), or severe
allergic responses.
10. Alcohol or drug abuse within the past 6 months, or current mental condition
(psychiatric disorder, senility or dementia), which may affect study compliance or
prevent understanding of the aims, investigational procedures or possible
consequences of the study.
11. Current or planned chronic administration of strong oral or injectable cytochrome P-
450 isoenzyme 3A4 (CYP3A4) inhibitors.15
12. Subjects with both parents of Japanese, Chinese, or Korean ancestry must have a
blood sample collected for assessment of Lp-PLA2 activity by the central laboratory
prior to randomization. Those with Lp-PLA2 activity &#8804;10 nmol/min/mL will be
excluded from participation in the study.16
13. Previous exposure to darapladib (SB-480848).
14. Use of another investigational product within 30 days or 5 half-lives (whichever is
the longer) preceding the first dose of darapladib or matching placebo.
15. Currently in a study of an investigational device.
16. Any other reason the investigator deems the subject to be unsuitable for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified