Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction

Summary

This is a double-blind, multicenter, randomized, placebo-controlled clinical trial. It is planned to enroll patients admitted with anterior ST-segment elevation myocardial infarction (STEMI) within 6h of symptom onset and undergo primary percutaneous coronary intervention (pPCI). Patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (DEX) group or the placebo (saline) group after signing the informed consent. In the DEX group, intravenous injection of DEX was started immediately after enrollment, covering the entire PCI operation, and the administration was stopped at the end of the pPCI. The administration of saline was the same as those in the DEX group. The primary endpoint was the myocardial infarct size (MIS) as assessed by cardiac magnetic resonance imaging (CMR) at 5±2 days post-STEMI. Based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a SD of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).

Conditions

• ST-segment Elevation Myocardial Infarction (STEMI)
• Percutaneous Coronary Intervention
• Cardioprotection

Interventions

DRUG

Dexmedetomidine (DEX)

The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.

DRUG

Placebo (Saline)

The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX.

Sponsors & Collaborators

• Yangtze River Pharmaceutical Group Co., Ltd.

  collaborator INDUSTRY

• Harbin Medical University

  lead OTHER

Principal Investigators

• Bo Yu, M.D., FACC · The Second Affiliated Hospital of Harbin Medical University

• Xi Su · Wuhan Asia Heart Hospital

• Xiaohui Zheng · Henan Provincial People's Hospital

• Kai Liu · Mudanjiang cardiovascular hospital

• Jian An · Shanxi Cardiovascular Hospital

• Xiling Shou · Shaanxi Provincial People's Hospital

• Chengzhi Lu · Tianjin First Central Hospital

• Xianhe Lin · The First Affiliated Hospital of Anhui Medical University

• Zheng Zhang · LanZhou University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-27

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• China

Study Locations