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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
ID06465303

Study of RTP-026 Safety and Effectiveness in Adults with ST-Elevation Myocardial Infarction STEMI Receiving Primary PCI

Led by ResoTher Pharma · Updated on 2025-09-22

96

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating RTP-026, a drug, in an exploratory, randomized, double-blind, multicenter, placebo-controlled clinical trial for patients with ST-elevation myocardial infarction STEMI. The study focuses on men aged 18 to 85 and post-menopausal women up to 85 years, all with recent chest pain lasting less than 12 hours and specific blood cell count ranges at hospital admission. The goal is to assess the safety, tolerability, and efficacy of RTP-026 compared to placebo in this acute heart condition. Participants will receive three 30-minute intravenous infusions of RTP-026 or placebo. The first infusion is started within 2 hours after blood flow is restored following primary Percutaneous Coronary Intervention PCI, with the next two infusions given at 8-hour intervals. The study includes different dosing levels of RTP-026 to be evaluated. During the study, participants will undergo assessments of cardiac markers, including changes in Cardiac Troponin T and Creatinine kinase-MB levels at 24 hours. Safety and tolerability will also be monitored. The total duration involves these infusions and close follow-up to measure the effects of the treatment and any side effects. The trial aims to provide detailed data on the investigational drugs impact in the critical period after STEMI.

CONDITIONS

Brief Title

A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

Research Team

I

Irene Sandholdt

S

Samra J Sanni, PhD

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