Sodium Thiosulfate to Preserve Cardiac Function in STEMI
Status:
Active, not recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Rationale: Timely and effective reperfusion by primary percutaneous coronary intervention
(PPCI) is currently the most effective treatment of ST-segment elevation myocardial
infarction (STEMI). However, permanent myocardial injury related to the ischemia and
subsequent reperfusion is observed in the vast majority (88%) of patients and harbours a risk
of heart failure development. Administration of hydrogen sulfide (H2S) has been shown to
protect the heart from "ischemia reperfusion injury" in various experimental models. Data in
humans suggests that the H2S-releasing agent sodium thiosulfate (STS) can be administered
safely.
Objective: to evaluate the efficacy and safety of STS compared to placebo treatment on
myocardial infarct size in patients presenting with STEMI and treated with PCI
Study design: a multicenter, double blind, randomized controlled clinical trial. A total of
380 patients, aged 18 years and above, undergoing primary PCI for a first STEMI and deemed
amenable, by the investigator, to be treated with STS 12.5g intravenously (i.v.) or matched
placebo immediately after arrival at the catheterization laboratory (cath-lab) and a repeated
dose administered 6 hours after the first dose, on top of standard treatment. Primary
endpoint is infarct size as measured with cardiac magnetic resonance imaging (CMR-imaging) 4
months after randomization.