A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multinational, Clinical Trial to Evaluate the Efficacy and Safety of Ranolazine vs Placebo in Patients With Non-ST Segment Elevation Acute Coronary Syndromes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,560
- 试验地点
- 1
- 主要终点
- Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS.
研究概览
简要总结
MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.
详细描述
Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, Skene A, McCabe CH, Braunwald E; MERLIN-TIMI 36 Investigators. Evaluation of a novel anti-ischemic agent in acute coronary syndromes: design and rationale for the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-elevation acute coronary syndromes (MERLIN)-TIMI 36 trial. Am Heart J. 2006 Jun;151(6):1186.e1-9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with non-ST elevation acute coronary syndrome
- •Ischemic symptoms (more than or equal to 5 minutes) at rest within 48 hours of study entry
- •At least one additional risk factor (e.g., elevated cardiac enzymes, ST-depression, diabetes)
排除标准
- •Persistent acute ST-segment elevation
- •Successful revascularization during the qualifying hospitalization, prior to study entry
- •Acute pulmonary edema, hypotension, or evidence of cardiogenic shock
- •Clinically significant liver disease
- •End stage kidney disease requiring dialysis
- •Concomitant use of drugs known to prolong the QT interval, or any digitalis drugs
- •Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4
- •Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control
- •Additional study entry criteria will be evaluated during initial screening.
研究组 & 干预措施
1
Ranolazine
干预措施: Ranolazine (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS.
时间窗: First occurrence
次要结局
- Composite of cardiovascular death, myocardial infarction, or severe recurrent ischemia. Safety of long-term treatment with ranolazine compared to placebo; safety endpoints are death from any cause and symptomatic documented arrhythmia.(First occurence)