Perioperative Ischemic Evaluation Study (POISE) Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8,351
- 试验地点
- 1
- 主要终点
- major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest)
研究概览
简要总结
This trial will evaluate the ability of metoprolol (a beta-blocker drug) to prevent heart attacks and deaths around the time of surgery.
详细描述
The POISE Trial is a large multi-centre, blinded, randomized controlled group trial of metoprolol vs placebo in 10,000 at risk patients undergoing noncardiac surgery. The POISE Trial will determine the impact of perioperative administration of metoprolol on cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) during the 30 day post-operative period in at risk patients undergoing noncardiac surgery.
Assuming a control group event rate of 6% for our primary outcome, we determined randomization of 8000 patients would provide 85% power and 10,000 patients 92% power to detect a relative risk reduction of 25% (two-sided alpha = 0.05). We set a goal to randomize 10,000 patients recognizing that we would have adequate power if we randomized 8000 patients. Without knowledge of the trial results and knowing that we had randomized more than 8000 patients and had a higher than predicted event rate, the Operations Committee decided to terminate recruitment on July 31, 2007 primarily because the remaining study drug expired in September 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing noncardiac surgery
- •≥ 45 years of age; either sex.
- •Have an expected length of stay ≥ 24 hours
- •Fulfill any one of the following 6 criteria:
- •coronary artery disease;
- •peripheral vascular disease;
- •history of stroke due to atherothrombotic disease;
- •hospitalization for congestive heart failure within 3 years of randomization;
- •undergoing major vascular surgery; OR
- •any 3 of the following 7 criteria: scheduled for high risk surgery (i.e. intraperitoneal or intrathoracic); emergency/urgent surgery; any history of congestive heart failure; history of a transient ischemic attack (TIA); diabetes and currently on an oral hypoglycemic agent or insulin therapy; preoperative serum creatinine > 175 µmol/L (> 2.0 mg/dl); or age > 70 years.
排除标准
- •Contraindication to metoprolol including any of the following: significant bradycardia (heart rate < 50 beats per minute); second or third degree heart block without a pacemaker; asthma that has been active within the last decade; and history of chronic obstructive pulmonary disease (COPD) with bronchospasm on pulmonary function tests.
- •Clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days
- •Prior adverse reaction to a beta-blocker
- •Coronary artery bypass graft (CABG) surgery with complete revascularization in the preceding 5 years and no evidence of cardiac ischemia since the CABG surgery
- •Patients undergoing low risk surgical procedures (potential examples include transurethral procedures [transurethral prostatectomies (TURPs), stone baskets, etc.], ophthalmologic procedures under topical or regional anesthesia [cornea transplants, cataract surgery, etc.], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs, etc.] )
- •Concurrent use of verapamil
- •Prior enrollment in this trial
研究组 & 干预措施
A
metoprolol
干预措施: Metoprolol controlled release (CR) (Drug)
B
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest)
时间窗: 30 days
次要结局
- clinically significant atrial fibrillation rehospitalization for cardiac reasons(30 days and 1 year)
- nonfatal myocardial infarction(30 days and 1 year)
- nonfatal cardiac arrest(30 days and 1 year)
- cardiovascular death(30 days and 1 year)
- total mortality(30 days and 1 year)
- revascularization procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty)(30 days and 1 year)
- congestive heart failure(30 days and 1 year)
- clinically significant bradycardia(30 days)
- clinically significant hypotension(30 days)
- nonfatal stroke(30 days)