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

NCT ID: NCT06465303

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2025-12-21

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).

Detailed 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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RTP-026

Group Type: EXPERIMENTAL

RTP-026

Intervention Type: DRUG

Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Intervention is for each subject administered as three 30-minutes infusions of placebo

Interventions

RTP-026

Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;

Intervention Type: DRUG

Placebo

Intervention is for each subject administered as three 30-minutes infusions of placebo

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResoTher Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Engstrøm, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Hjertecenteret, Rigshospitalet, Denmark

Locations

Hjertecenteret, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Irene Sandholdt

Role: CONTACT

isa@croxxmed.com

+45 2015 7033

Samra J Sanni, PhD

Role: CONTACT

sas@resotherpharma.com

+45 3120 8857

Facility Contacts

Thomas Engstrøm, Prof. MD

Role: primary

Other Identifiers

ResoTher-CS002

Identifier Type: -

Identifier Source: org_study_id