ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction

Phase 4 Completed 40 enrolled Beijing Anzhen Hospital China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI

Timeline

Start: 2016-04
Primary completion: 2018-02
Completion: 2018-02

Outcome

Missed primary endpoint

paper Infarct size by area under the curve for CK-MB over 72 h did not differ between the Shenfu injection and placebo groups PMID 34926601 ↗

paper did not reduce infarct size by CMR Imaging and CK-MB release kinetics in reperfused patients with STEMI PMID 34926601 ↗

Publications

Wang X, Miao H, Yan Y, Guo R, Gong W, He Y, Wang H, Ma X, Nie S. Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial. Front Cardiovasc Med. 2021 Dec 3;8:736526. doi: 10.3389/fcvm.2021.736526. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Shenfu Injection	Traditional medicine (herbal / TCM)	80 ml	Intravenous