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Recruiting Phase 2 NCT06465303

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

Trial Parameters

Condition ST Elevation Myocardial Infarction
Sponsor ResoTher Pharma
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 96
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2024-07-16
Completion 2025-12-21
Interventions
RTP-026Placebo

Brief 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).

Eligibility Criteria

Inclusion Criteria: * Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures * Men between 18-85 years of age and post-menopausal women up to 85 years of age * Acute onset of chest pain of \< 12 hours duration * STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI) * Eligible for primary PCI * NLR in the range of 7-17 at hospital admission. In patients with chest pain lasting \> 3 - ≤ 6 hours at admission, the NLR should be in the range of 4.8-17 and for patients with chest pain lasting ≤ 3 hours at admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9/L, irrespective of the lymphocyte coun

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