跳至主要内容
临床试验/NCT01715714
NCT01715714已完成4 期

Statin Recapture Therapy Before Coronary Artery Bypass Grafting

University of Cologne10 个研究点 分布在 1 个国家目标入组 2,630 人开始时间: 2012年11月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
2,630
试验地点
10
主要终点
Major adverse cardiocerebral events (MACCE) within 30 days after CABG.

研究概览

简要总结

Patients with coronary artery disease requiring coronary artery bypass grafting (CABG) are at risk for postoperative complications after surgery. The StaRT-CABG trial is the first large-scale (2,630 patients) that will investigate whether an additional treatment with statins (lipid-lowering medication) in high doses before CABG surgery can reduce the incidence of major post-surgery complications including death, myocardial infarction and stroke. The StaRT-CABG trial will be recruiting patients from 8 cardiac surgery centres in Germany and is expected to provide relevant clinical data on the efficacy of this novel treatment in order to optimize the care for all patients undergoing CABG.

详细描述

Patients with coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiocerebral events (≈15% MACCE rate), with ≈3% of patients dying within 30 days of surgery. Recent clinical evidence shows that cardioprotection in patients receiving chronic statin treatment can be further improved by a high-dose statin 'recapture' therapy given shortly before an ischemia-reperfusion sequence, resulting in a 61% risk reduction for MACE at 30 days in patients undergoing PCI. Evaluation of this novel approach in the setting of CABG seems particularly promising, as myocardial injury, surgery-related inflammation and pre-existing patients' comorbidities play a pivotal role for poor clinical outcomes after CABG that may be improved by an acute statin recapture therapy. The StaRT-CABG trial is the first large-scale (n=2,630 CABG patients), multicentre (8 cardiac surgery centres), randomised, double-blind and placebo-controlled trial that aims to test whether an acute high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (composite primary outcome: all-cause mortality; non-fatal myocardial infarction and cerebrovascular events). The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach in order to optimize the care for all CAD patients undergoing CABG with broad clinical implications on current clinical practice and existing guidelines.

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

入选标准

  • Patients on chronic statin treatment (>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures
  • Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
  • Age ≥ 18 years
  • Written informed consent

排除标准

  • Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
  • Acute ST-segment-elevation myocardial infarction (STEMI)
  • NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission
  • History of atrial fibrillation or muscle disease (myopathy)
  • Current renal (creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)
  • Inability of oral drug intake

研究组 & 干预措施

Statin Recapture Therapy

Active Comparator

Oral statin reload of patients at 12 and 2 hours before CABG using the maximal dose of the chronically prescribed statin* on admission. (*simvastatin 80 mg, atorvastatin 80 mg, fluvastatin 80 mg or pravastatin 40 mg)

干预措施: Statin Recapture Therapy (Drug)

Placebo

Placebo Comparator

Placebo given orally 12 hrs and 2 hrs before CABG

干预措施: Placebo (Drug)

结局指标

主要结局

Major adverse cardiocerebral events (MACCE) within 30 days after CABG.

时间窗: 30 days after Surgery

Composite endpoint consisting of (1) all-cause mortality, (2) non-fatal myocardial infarction (MI) and (3) non-fatal cerebrovascular event (stroke or TIA).

次要结局

  • Major adverse cardiac events(30 days after Surgery)
  • Length of stay(within the first 15 days after surgery (plus or minus 5 days))
  • Wound Infections(30 days after surgery)
  • Mortality at 12 months(12 months after surgery)
  • Repeat coronary revascularisation(30 days after surgery)
  • Atrial fibrillation(within the first 15 days after surgery (plus or minus 5 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PD Dr. Oliver J. Liakopoulos

Principal Investigator

University of Cologne

研究点 (10)

Loading locations...

相似试验