CTIS2023-509182-21-00Active, not recruitingPhase 1
An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with ST-Elevation Myocardial Infarction (STEMI)
ResoTher Pharma A/S0 sites96 target enrollmentStarted: February 20, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 96
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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 (menstrual periods stopped at least 12 months ahead of the enrolment in the trial), 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 (measured in a point-of-care testing device)
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 (except basal cell carcinoma of the skin that has been excised and cured), 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 (e.g., psychiatric disorders, dementia), Known contraindications to CMR, ORBI Risk Score > 10
Investigators
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