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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorResoTher Pharma

About this trial

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

Qualifiers

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)

Disqualifiers

Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry

Previous exposure to RTP-026

Time from symptoms onset to primary PCI > 12 hours

Previous CABG

Trial design

Treatments tested in this trial

  • RTP-026
  • Placebo

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators