Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT06465303

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

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

96

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent before starting any study procedures
  • Men between 18 and 85 years old or post-menopausal women up to 85 years old
  • Chest pain started less than 12 hours ago
  • Confirmed STEMI by ECG criteria
  • Eligible for primary Percutaneous Coronary Intervention (PCI)
  • Neutrophil to lymphocyte ratio (NLR) between 7 and 17 at hospital admission; for chest pain lasting more than 3 to 6 hours or less than 3 hours, NLR between 4.8 and 17 or neutrophil count at least 9 x 10^9/L regardless of lymphocyte count
  • For anterior or anterolateral infarction STEMI patients, NLR at least 3
Not Eligible

You will not qualify if you...

  • Participated in another investigational drug study within the past 4 weeks
  • Previous exposure to RTP-026
  • Time from symptom onset to primary PCI more than 12 hours
  • Previous coronary artery bypass graft surgery (CABG)
  • Active malignant disease
  • Currently on immune suppressive treatment
  • Any condition that may prevent compliance with the study protocol
  • Known contraindications to cardiac magnetic resonance imaging (CMR)
  • ORBI Risk Score greater than 12

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hjertecenteret, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

I

Irene Sandholdt

CONTACT

S

Samra J Sanni, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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