Ivabradine for PREVENTion of Myocardial Injury After Noncardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,146
- 试验地点
- 26
- 主要终点
- MINS
研究概览
简要总结
This study is a multicentre, randomized controlled trial of ivabradine versus placebo.
详细描述
The PREVENT-MINS study is a 2,500 patient multicentre, superiority randomized controlled trial of ivabradine versus placebo. The primary objective of the trial is to determine the impact of ivabradine versus placebo on the risk of MINS in patients with or at risk of atherosclerotic disease who are followed for 30 days after noncardiac surgery.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing noncardiac surgery
- •≥45 years of age
- •Expected to require at least an overnight hospital admission after surgery
- •Provide written informed consent to participate in the PREVENT-MINS Trial, AND
- •Fulfill ≥1 of the following 5 criteria (A-E):
- •A. History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR
- •E. Any 3 of 9 risk criteria:
- •i. Undergoing major surgery ii. History of congestive heart failure iii. History of a transient ischaemic attack iv. Diabetes and currently taking an oral hypoglycemic agent or insulin v. Age ≥70 years vi. History of hypertension vii. Serum creatinine >175 µmol/L (>2.0 mg/dl) viii. History of smoking within 2 years of surgery ix. Undergoing emergent/urgent surgery
排除标准
- •Conduction abnormalities:
- •A. Non-sinus rhythm on ECG B. Sinoatrial or AV (2nd and 3d degree) blocks C. Sick sinus syndrome D. Long QT syndrome E. Pacemaker dependent
- •Transplanted heart (or on waiting list)
- •Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil
- •Resting heart rate <65 beats per minute on the day of surgery
- •Systolic blood pressure <90 mmHg on the day of surgery
- •Acute decompensated heart failure, cardiogenic shock, acute myocarditis
- •Acute coronary syndrome within 2 months before surgery;
- •Stroke or transient cerebral ischaemia within 1 month before surgery
- •Known severe liver or kidney disease (MDRD creatinine clearance <15 mL/min)
- •Inability to tolerate oral intake
- •Recent use of ivabradine (<1 month)
- •Known allergy or hypersensitivity to ivabradine
- •Low-risk surgical procedure based on individual physician's judgment
- •Investigator considers the patient unreliable regarding requirement for study compliance
- •Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
- •Previously enrolled in the PREVENT-MINS study
研究组 & 干预措施
Ivabradine
Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge.
干预措施: Ivabradine (Drug)
Placebo
Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge.
干预措施: Placebo (Drug)
结局指标
主要结局
MINS
时间窗: 30 days after randomization
Number of patients who experience myocardial injury after non-cardiac surgery (MINS) defined as any myocardial infarction and any elevated postoperative cardiac troponin judged as resulting from myocardial ischaemia during or within 30 days after noncardiac surgery.
次要结局
- All-cause mortality(30 days after randomization)
- MINS not fulfilling the 4th universal definition of myocardial infarction(30 days after randomization)
- Myocardial infarction(30 days after randomization)
- A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest(30 days after randomization)
- Vascular death(30 days after randomization)
- Stroke(30 days after randomization)
- Days alive and at home(30 days after randomization)
- Health-related quality of life(30 days after randomization)
- Clinically important atrial fibrillation(30 days after randomization)
- Clinically significant bradycardia(30 days after randomization)
- Clinically significant hypotension(30 days after randomization)
- Phosphenes(30 days after randomization)
- Cancellation or postponement of surgery due to concerns about patient's heart rate(30 days after randomization)
- Peak troponin concentration(30 days after randomization)
- Area under the curve troponin(30 days after randomization)
- Intraoperative mean arterial pressure(30 days after randomization)
- Intraoperative heart rate(30 days after randomization)
研究者
Wojciech Szczeklik
Principal Investigator Wojciech Szczeklik MD PhD
Jagiellonian University