One-year Outcome of Intensive Versus Standard Blood Pressure Treatment in Non-ST Elevation Acute Coronary Syndrome: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- combined mortality and MACE rate
研究概览
简要总结
The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term.
the study compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.
详细描述
Acute coronary syndrome is often associated with arterial pressure elevation which are deleterious for the heart and needs urgent intervention to lower the blood pressure to the required values, however there is no clear recommendations concerning the treatment intensity in this situation.
The investigators know that high arterial pressure increases the oxygen myocardial consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce intensively this pressure.
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
- Single (Investigator)
盲法说明
The assessments of outcome is conducted by aninvestigator who did not participate in the randomization, protocol treatment or in-hospital clinical treatment of the patient.
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-ST segment elevation Acute Coronary Syndrome
排除标准
- •SBP under 90 mmHg or hemodynamic instability
- •Complicated ACS (arrythmias, atrio-ventricular block, shock, tamponade...) or ST elevation myocardial infarction (STEMI)
- •Patients with contraindication to nitrates and/or beta blockers
研究组 & 干预措施
intensive controle group
The end point in this group was to maintain the systolic blood pressure (SBP) between 110 and 120 mmHg using continuous intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed.
干预措施: Isosorbide Dinitrate (Drug)
standard control group
The end point in these group was to maintain the systolic blood pressure under 140 mmHg using continuous intravenous Isosorbide Dinitrate perfusion, and Labetalol if needed.
干预措施: Isosorbide Dinitrate (Drug)
结局指标
主要结局
combined mortality and MACE rate
时间窗: 1 year
combined mortality and MACE rate at one year.
major cardiovascular events (MACE)
时间窗: 12months
1-year MACE rate
mortality
时间窗: 12 months
1-year death rate
次要结局
- troponin change(24 hours after baseline measurement)
- Adverse events(24 hours after start of protocol intervention)
研究者
Pr. Semir Nouira
professor
University of Monastir