An Exploratory, Randomised, Double-blind Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

ST Elevation Myocardial Infarction Clinical Trial

Official title:

An Exploratory, Randomised, Double-blind, Multicentre, Placebo-controlled Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465303
• Other study ID #: ResoTher-CS002
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2024
• Est. completion date: December 21, 2025

Study information

• Verified date: June 2024
• Source: ResoTher Pharma
• Contact: Irene Sandholdt
• Phone: +45 2015 7033
• Email: isa[@]croxxmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 18-80 years and post-menopausal women up to 80 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 7-17 at hospital admission/right after the PCI.

They 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 21, 2025
• Est. primary completion date: December 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures

• Men between 18-80 years of age and post-menopausal women up to 80 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 or right after the PCI

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 > 10

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• RTP-026
Intervention is divided into 3 groups. Group A: Infusion of 25µg/kg RTP-026 or placebo Group B: Infusion of = 26µg/kg and =75µg/kg RTP-026 or placebo Group C: Infusion of a maximum of 3 x treatment dose RTP-026 or placebo given in Group B The treatment is given as three 30-minutes infusions prepared with the actual dose corresponding to Group A, B or C.

Locations

Country	Name	City	State
Denmark	Hjertecenteret, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
ResoTher Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiac Troponin T (cTNT)	Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.	24 hours
Primary	Change in Creatinine kinase-MB (CK-MB)	Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.	24 hours