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

ResoTher Pharma

Status and phase

Enrolling

Phase 2

Conditions

ST Elevation Myocardial Infarction

Treatments

Drug: RTP-026

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06465303

ResoTher-CS002

Details and patient eligibility

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).

Full 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 18-85 years and post-menopausal women up to 85 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 3-17 at hospital admission (Please refer to inclusion criteria).

The participants 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.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3.

Exclusion criteria

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
Evidence of active malignant disease
Ongoing treatment with immune suppressive compounds
Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures
Known contraindications to CMR
ORBI Risk Score > 12