Coronary Heart Disease
Conditions
Keywords
CHD, coronary heart disease, atherosclerosis, inflammation
Brief summary
Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).
Interventions
DRUGSB-681323
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Females must be of non-child-bearing potential. * Female subjects must have a negative pregnancy test. * Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography. * Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL \<130 mg/dL (3.4 mmol/L) at Screening visit. * Must be capable of providing informed consent. * Have an hsCRP concentration of \>2 mg/L, but \< 10 mg/L at screening.
Exclusion criteria
* Women who are pregnant or breast feeding. * Planned PCI with multi-vessel stenting. * Planned PCI with additional revascularization procedures staged at different days during the study period. * Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc). * Planned PCI of any bypass graft. * History of CABG surgery. * Planned cardiac or major non-cardiac surgery within the study period. * Disabling stroke in the past 6 months. * History of chronic viral hepatitis or other chronic hepatic disorders. * History of Gilbert's syndrome or elevated bilirubin concentrations at screening. * History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months. * Renal impairment with serum creatinine \>2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy. * Current inadequately controlled hypertension (blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic) on a stable dose of antihypertensive medication. * Current poorly controlled diabetes mellitus, defined as HbA1c \>10% at Screening. * History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF\<30%) regardless of symptomatic status. * History of malignancy within the past 5 years, other than non-melanoma skin cancer. * Current life-threatening condition other than vascular disease that may prevent a subject from completing the study. * Alcohol or drug abuse within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein) | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics | 28 days |
Countries
Denmark, Poland
Outcome results
None listed