Cardioprotective Effect of Dexmedetomidine in Patients With ST-segment Elevation Myocardial Infarction
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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%).