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
- Conditions
- Subjects with myocardial infarction without ST-segment elevationMedDRA version: 9.1Level: LLTClassification code 10064347Term: Non ST segment elevation myocardial infarction
- Registration Number
- EUCTR2009-010615-32-NL
- Lead Sponsor
- GlaxoSmithKline R&D Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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will not be withdrawn from study].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:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory), or
• Child-bearing potential and agrees to use one of the contraception methods listed in Section 7.1.1 of the protocol for the duration of dosing and until the first follow-up visit (~2 weeks post last-dose).
6. Negative urine or serum pregnancy test (in women of child-bearing potential only).
7. Male subjects must agree to use one of the contraception methods listed in Section 7.1.2 of the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (~2 weeks post last-dose).
8. QTcB or QTcF 9. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
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
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.
7. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
8. Known to be Hepatitis B or Hepatitis C positive.
9. Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal
and topical steroids are allowed. A single prophylactic dose of systemic steroid
is allowed at time of PCI for subjects with contrast allergy.
10. Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone);
Previously diagnosed cancer that has not been in complete remission for at least
5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix
that have been resected or ablated for cure are not exclusionary.11.
12. Known alcohol or drug abuse within the past 6 months.
13. Previous exposure to GW856553.
14. Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study.
15. Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication noncompliance).
16. Unwillingness or inability to follow the procedures outlined in the protocol.
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