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 ST segment elevation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 6
- 主要终点
- To assess the safety of GW856553 in subjects with NSTEMI.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study is being conducted to evaluate the effects of GW856553X (where X indicates free base) in subjects with non-ST segment elevation myocardial infarction (NSTEMI). The primary objectives are assessments of safety, inflammatory markers and infarct size. Up to approximately 500 subjects will be randomized to ensure up to ~400 evaluable subjects complete 12 weeks of dosing. All subjects will continue to receive the local standard of care for the duration. Subjects will be assigned to:7.5 mg GW856553 starting dose, followed 12 (± 4) hours later by 7.5 mg BID GW856553 OR 15 mg GW856553 starting dose, followed 12 (± 4) hours later by 7.5 mg BID GW856553 OR placebo in the ration of 3:3:2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with a NSTEMI, defined as: ?symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms 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 18 hours of presentation. 3.Male or female subject who is
- •65 years of age, inclusive. 4.QTcB or QTcF ≤ 530 msec.
排除标准
- •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, Severe aortic stenosis or other severe valvular disease.3.Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.4.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.5.History of myopathy or rhabdomyolysis.6.Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).7.Known to be Hepatitis B or Hepatitis C positive.8.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.9.Current or anticipated use of BCRP substrates with a narrow therapeutic index 10.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 havebeen resected or ablated for cure are not exclusionary.11.Known alcohol or drug abuse within the past 6 months.12.Previous exposure to GW856553.
结局指标
主要结局
To assess the safety of GW856553 in subjects with NSTEMI.
时间窗: Inflammatory Endpoints | Primary | hsCRP at Week 12
To assess the effects of GW856553 on biomarkers of inflammation in subjects with NSTEMI over the 12 weeks of treatment.
时间窗: Inflammatory Endpoints | Primary | hsCRP at Week 12
To assess the effects of GW856553 on infarct size and cardiac function during the peri-infarct period and during the ensuing 12 weeks of treatment
时间窗: Inflammatory Endpoints | Primary | hsCRP at Week 12
次要结局
- hsCRP over hospitalization period and through Week 14