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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: ST Elevation Myocardial Infarction

In brief

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).

Key facts

Study ID

NCT06465303

Run by

ResoTher Pharma

People needed

96

Starts

2024-07-16

Expected to finish

2025-12-21

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Hjertecenteret, Rigshospitalet — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.