EUCTR2009-010615-32-NL
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers, infarct size, and cardiac function in subjects with myocardial infarction without STsegmentelevation - SOLSTICE
GlaxoSmithKline R&D Ltd0 sites400 target enrollmentOctober 22, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subjects with myocardial infarction without ST-segment elevation
- Sponsor
- GlaxoSmithKline R&D Ltd
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects with a NSTEMI, defined as:
- •symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, and occurring within the 24 hours prior to presentation,
- •without persistent ST\-segment elevation on admission 12\-lead ECG, and
- •with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation.
- •2\. Subject able to be randomized within 12 hours of presentation.
- •3\. Subjects likely to be managed with an early invasive strategy, with PCI likely to
- •occur at least 2 hours after the start of dosing.\[subjects who do not undergo PCI
- •will not be withdrawn from study].
- •4\. Male or female subject who is 45 years of age or older.
- •5\. A female subject is eligible to participate if she is of:
Exclusion Criteria
- •1\. History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction \[ejection fraction (EF) \< 30%] regardless of symptomatic status.
- •2\. Suspected aortic dissection.
- •3\. Severe aortic stenosis or other severe valvular disease.
- •4\. Current known life\-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
- •5\. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions
- •known to be associated with active chronic or acute inflammation (e.g. inflammatory
- •bowel disease, osteomyelitis, pneumonia, sepsis, etc.). Intermittent conditions
- •treated with short\-term oral antibiotics (e.g. typical URI), or conditions that are
- •not currently exacerbated (e.g. gout with no current flair) may be included.
- •6\. History of myopathy or rhabdomyolysis.
Outcomes
Primary Outcomes
Not specified
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