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An Exploratory, Randomised, Double-blind Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

ST Elevation Myocardial Infarction Clinical Trial

Official title:
An Exploratory, Randomised, Double-blind, Multicentre, Placebo-controlled Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

Clinical Trial Summary

This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026. The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).

Clinical Trial Description

An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with (STEMI). The study population is men between 18-80 years and post-menopausal women up to 80 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting <12 hours and neutrophil to lymphocyte ratio (NLR) in the range of 7-17 at hospital admission/right after the PCI. They will be given three 30-minute intravenous infusions of RTP-026 or placebo (the investigational product). The first dose is to be initiated within 2 hours following the establishment of reflow after PCI, and the following two study treatments with 8-hour intervals. The purpose of this study is to evaluate the safety, tolerability and efficacy of RTP-026 versus placebo in multiple doses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06465303
Study type Interventional
Source ResoTher Pharma
Contact Irene Sandholdt
Phone +45 2015 7033
Email isa@croxxmed.com
Status Recruiting
Phase Phase 2
Start date June 10, 2024
Completion date December 21, 2025
View Details
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