Patients with ST-Elevation Myocardial Infarction (STEMI)
Conditions
Brief summary
The primary safety endpoint: To compare the safety and tolerability of RTP-026 against placebo by evaluating adverse events (AEs), serious adverse events (SAEs), vital signs, ECGs, and laboratory abnormalities., To compare the effect of RTP-026 against placebo by assessing the following by treatment group: Change in cTnT and CK-MB determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI
Detailed description
Initial MSI defined as the ratio between IS and AAR determined within 48 hours post-PCI determined by CMR, MSI determined by CMR 90 days post-PCI, IS determined by CMR within 48 hours post-PCI, IS determined by CMR 90 days post-PCI, Myocardial oedema determined by CMR within 48 hours post-PCI, Change in IS from initial determination of IS within 48 hours post-PCI to 90 days post-PCI determined by CMR, Effects on LVEF determined by CMR 48 hours post-PCI, Effects on LVEF determined by CMR 90 days post-PCI, Changes in Pro-BNP, hsCRP and NLR determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI, The composite of death and MACE (defined as CV mortality, admission due to recurrent AMI or HF up to day 28 post-PCI, The composite of death and MACE up to day 90 post-PCI, Days to discharge from hospital
Interventions
DRUGRTP-026 Placebo
DRUGRTP-026
Sponsors
ResoTher Pharma A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint: To compare the safety and tolerability of RTP-026 against placebo by evaluating adverse events (AEs), serious adverse events (SAEs), vital signs, ECGs, and laboratory abnormalities., To compare the effect of RTP-026 against placebo by assessing the following by treatment group: Change in cTnT and CK-MB determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial MSI defined as the ratio between IS and AAR determined within 48 hours post-PCI determined by CMR, MSI determined by CMR 90 days post-PCI, IS determined by CMR within 48 hours post-PCI, IS determined by CMR 90 days post-PCI, Myocardial oedema determined by CMR within 48 hours post-PCI, Change in IS from initial determination of IS within 48 hours post-PCI to 90 days post-PCI determined by CMR, Effects on LVEF determined by CMR 48 hours post-PCI, Effects on LVEF determined by CMR 90 days post-PCI, Changes in Pro-BNP, hsCRP and NLR determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI, The composite of death and MACE (defined as CV mortality, admission due to recurrent AMI or HF up to day 28 post-PCI, The composite of death and MACE up to day 90 post-PCI, Days to discharge from hospital | — |
Countries
Denmark, Sweden
Outcome results
None listed