Evaluating RTP-026 for safety and effectiveness in heart attack patients

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)

This study is testing if a new treatment called RTP-026 can help heart attack patients feel better after their procedure compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: ResoTher Pharma (Industry-sponsored)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06465303 on ClinicalTrials.gov

What this trial studies

This clinical trial is an exploratory, randomized, double-blind, multicentre, placebo-controlled study designed to assess the safety, tolerability, and efficacy of RTP-026 in patients experiencing ST-elevation myocardial infarction (STEMI). Participants will receive three intravenous infusions of RTP-026 or a placebo, starting within two hours after primary Percutaneous Coronary Intervention (PCI). The study focuses on men and post-menopausal women aged 18 to 80 with acute chest pain lasting less than 12 hours and specific neutrophil to lymphocyte ratios. The goal is to determine if RTP-026 can improve outcomes compared to placebo in this patient population.

Who should consider this trial

Good fit: Ideal candidates are men aged 18-80 and post-menopausal women up to 80 years with documented STEMI and specific clinical criteria.

Not a fit: Patients who have had symptoms for more than 12 hours or have previous heart surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from STEMI, potentially enhancing recovery and reducing complications.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in evaluating new treatments for acute myocardial infarction.

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

Where this trial is running

Copenhagen

• Hjertecenteret, Rigshospitalet — Copenhagen, Denmark (Recruiting)

Study contacts

• Principal investigator: Thomas Engstrøm, Prof. MD — Hjertecenteret, Rigshospitalet, Denmark
• Study coordinator: Irene Sandholdt

Conditions ST Elevation Myocardial Infarction