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Tests treatment safety and results for ST Elevation Myocardial Infarction
Official title A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
ClinicalTrials.gov ID: NCT06465303
What this study is testing
What is RTP-026?
RTP-026 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for st elevation myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- Eligible for primary PCI
You likely can't join 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.