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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).
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 18-85 years and post-menopausal women up to 85 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 3-17 at hospital admission (Please refer to inclusion criteria).
The participants 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTP-026 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTP-026 | Drug | Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B; |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Troponin T (cTNT) | Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI. | 24 hours |
| Change in Creatinine kinase-MB (CK-MB) | Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Sandholdt | Contact | +45 2015 7033 | isa@croxxmed.com | |
| Samra J Sanni, PhD | Contact | +45 3120 8857 | sas@resotherpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Engstrøm, Prof. MD | Hjertecenteret, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hjertecenteret, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Drug | Intervention is for each subject administered as three 30-minutes infusions of placebo |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |