A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
- Conditions
- ST Elevation Myocardial Infarction
- Interventions
- Drug: Placebo
- Registration Number
- NCT06465303
- Lead Sponsor
- ResoTher Pharma
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - RTP-026 RTP-026 -
- Primary Outcome Measures
Name Time Method Change in Cardiac Troponin T (cTNT) 24 hours Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.
Change in Creatinine kinase-MB (CK-MB) 24 hours Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hjertecenteret, Rigshospitalet
🇩🇰Copenhagen, Denmark