Actively Recruiting
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)
Led by ResoTher Pharma · Updated on 2025-09-22
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating RTP-026, a drug, in an exploratory, randomized, double-blind, multicenter, placebo-controlled clinical trial for patients with ST-elevation myocardial infarction (STEMI). The study focuses on men aged 18 to 85 and post-menopausal women up to 85 years, all with recent chest pain lasting less than 12 hours and specific blood cell count ranges at hospital admission. The goal is to assess the safety, tolerability, and efficacy of RTP-026 compared to placebo in this acute heart condition. Participants will receive three 30-minute intravenous infusions of RTP-026 or placebo. The first infusion is started within 2 hours after blood flow is restored following primary Percutaneous Coronary Intervention (PCI), with the next two infusions given at 8-hour intervals. The study includes different dosing levels of RTP-026 to be evaluated. During the study, participants will undergo assessments of cardiac markers, including changes in Cardiac Troponin T and Creatinine kinase-MB levels at 24 hours. Safety and tolerability will also be monitored. The total duration involves these infusions and close follow-up to measure the effects of the treatment and any side effects. The trial aims to provide detailed data on the investigational drug's impact in the critical period after STEMI.
CONDITIONS
Brief Title
A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent given before any study procedures
- Men aged 18 to 85 years and post-menopausal women up to 85 years
- Acute onset of chest pain lasting less than 12 hours
- Documented STEMI on ECG with specific ST elevation or new left bundle branch block criteria
- Eligible for primary Percutaneous Coronary Intervention (PCI)
- Neutrophil to lymphocyte ratio (NLR) in specified ranges depending on chest pain duration and infarction location
You will not qualify if you...
- Participation in another investigational drug study within 4 weeks before entry
- Previous exposure to RTP-026
- Time from symptom onset to primary PCI greater than 12 hours
- Previous coronary artery bypass graft (CABG) surgery
- Active malignant disease
- Ongoing treatment with immune suppressive drugs
- Any condition preventing compliance with study protocol
- Known contraindications to cardiac magnetic resonance imaging (CMR)
- ORBI Risk Score greater than 12
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 hours
Participants receive three 30-minute intravenous infusions of RTP-026 or placebo, starting within 2 hours after reflow is established following PCI, with 8-hour intervals between doses.
1 treatment period with 3 infusions over about 16 hours
Trial Site Locations
Total: 1 location
1
Hjertecenteret, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
I
Irene Sandholdt
S
Samra J Sanni, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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