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Randomized Evaluation of Shenfu Injection to Reduce Myocardial Injury — RESTORE  

Myocardial Infarction Clinical Trial

Official title:
Effect of Shenfu Injection on Myocardial Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled Clinical Trial

Clinical Trial Summary

This study aims to evaluate whether perioperative use of Shenfu Injection, as compared to placebo, could reduce infarct size assessed by cardiac magnetic resonance (CMR) in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Clinical Trial Description

Shenfu injection is a traditional Chinese medicine formulation containing ginseng (Panax; family: Araliaceae) and aconite (Radix aconiti lateralis preparata, Aconitum carmichaeli Debx; family: Ranunculaceae) with Ginsenosides and aconite alkaloids as the main active ingredients. Its quality is strictly controlled in compliance with the standard of the China Ministry of Public Health (official approval code: certification number Z20043117; No. 110804, Ya'an, China). Animal studies have shown that Shenfu injection has protective effects against reperfusion injury through multiple pharmacologic effects, including scavenging free radicals, inhibiting inflammatory mediators, suppressing cell apoptosis, and inhibiting calcium overload. However, few data are available regarding its efficacy in humans. We aimed to determine whether perioperative use of Shenfu injection, as compared to placebo, might reduce infarct size in patients with STEMI undergoing primary PCI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04493840
Study type Interventional
Source Beijing Anzhen Hospital
Contact Shao-Ping Nie, MD, PhD
Phone 86-10-84005256
Email spnie@ccmu.edu.cn
Status Recruiting
Phase Phase 4
Start date July 30, 2020
Completion date August 31, 2022
View Details
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