Clinical trial NCT06465303: A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: ResoTher Pharma
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 18-80 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cardiac Troponin T (cTNT)
timeFrame: 24 hours
measure: Change in Creatinine kinase-MB (CK-MB)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hjertecenteret, Rigshospitalet
Study officials:
affiliation: Hjertecenteret, Rigshospitalet, Denmark
name: Thomas Engstrøm, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: