RTP-026 SODIUM for ST-elevation myocardial infarction (STEMI) | Acute myocardial infarction

Inclusion criteria

• {"criterion_text":"- Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures"}
• {"criterion_text":"- Men between 18-85 years of age and post-menopausal women up to 85 years of age (menstrual periods stopped at least 12 months ahead of the enrolment in the trial)"}
• {"criterion_text":"- Acute onset of chest pain of < 12 hours duration"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Eligible for primary PCI"}
• {"criterion_text":"- NLR in the range of 7-17 at hospital admission (measured in a point-of-care testing device). 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 admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9/L, irrespective of the lymphocyte count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3. If it is not possible to measure NLR at admission, it must be measured before reflow is established."}

Exclusion criteria

• {"criterion_text":"- Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry"}
• {"criterion_text":"- Previous exposure to RTP-026"}
• {"criterion_text":"- Time from symptoms onset to primary PCI > 12 hours"}
• {"criterion_text":"- Previous CABG"}
• {"criterion_text":"- Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)"}
• {"criterion_text":"- Ongoing treatment with immune suppressive compounds"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Known contraindications to CMR"}
• {"criterion_text":"- ORBI Risk Score > 12"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Safety and tolerability assessed by recording adverse events (AEs), serious adverse events (SAEs), vital signs, ECGs and laboratory abnormalities."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Efficacy measured by change in cardiac troponin T (cTnT) and CK-MB measured in blood samples at Baseline, 6 hours, 12 hours and 24 hours post-PCI."}

Secondary endpoints

• {"endpoint_text":"- Initial MSI defined as the ratio between IS and AAR determined within 48 hours post-PCI determined by CMR","definition_or_measurement_approach":"Myocardial salvage index (MSI) = ratio of infarct size (IS) to area at risk (AAR) determined by cardiac magnetic resonance imaging (CMR) within 48 hours post-PCI."}
• {"endpoint_text":"- MSI determined by CMR 90 days post-PCI","definition_or_measurement_approach":"MSI measured by CMR at 90 days post-PCI."}
• {"endpoint_text":"- IS determined by CMR within 48 hours post-PCI","definition_or_measurement_approach":"Infarct size (IS) assessed by CMR within 48 hours post-PCI."}
• {"endpoint_text":"- IS determined by CMR 90 days post-PCI","definition_or_measurement_approach":"Infarct size assessed by CMR at 90 days post-PCI."}
• {"endpoint_text":"- Myocardial oedema determined by CMR within 48 hours post-PCI","definition_or_measurement_approach":"Myocardial oedema assessed by CMR within 48 hours post-PCI."}
• {"endpoint_text":"- Change in IS from initial determination of IS within 48 hours post-PCI to 90 days post-PCI determined by CMR","definition_or_measurement_approach":"Change in infarct size between the CMR within 48 hours and the CMR at 90 days post-PCI."}
• {"endpoint_text":"- Effects on LVEF determined by CMR 48 hours post-PCI","definition_or_measurement_approach":"Left ventricular ejection fraction (LVEF) measured by CMR 48 hours post-PCI."}
• {"endpoint_text":"- Effects on LVEF determined by CMR 90 days post-PCI","definition_or_measurement_approach":"LVEF measured by CMR at 90 days post-PCI."}
• {"endpoint_text":"- Changes in Pro-BNP, hsCRP and NLR determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI","definition_or_measurement_approach":"Biomarker changes (Pro-BNP, high-sensitivity CRP, neutrophil-to-lymphocyte ratio) measured in blood samples at Baseline, 6, 12 and 24 hours post-PCI."}
• {"endpoint_text":"- The composite of death and MACE (defined as CV mortality, admission due to recurrent AMI or HF up to day 28 post-PCI","definition_or_measurement_approach":"Composite endpoint of death and major adverse cardiovascular events (MACE: cardiovascular mortality, admission due to recurrent AMI or heart failure) assessed up to day 28 post-PCI."}
• {"endpoint_text":"- The composite of death and MACE up to day 90 post-PCI","definition_or_measurement_approach":"Composite endpoint of death and MACE assessed up to day 90 post-PCI."}
• {"endpoint_text":"- Days to discharge from hospital","definition_or_measurement_approach":"Number of days from admission/PCI to hospital discharge."}

Denmark

Earliest CTIS Part Ii Submission Date

30-04-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

216

Number Of Sites

3

Number Of Participants

86

Sweden

Earliest CTIS Part Ii Submission Date

03-11-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

21

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

ResoTher Pharma A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

PharmaLex Denmark A/S

Responsibilities

sponsorDuties codes: 8; contact email: Tale.Baroy@pharmalex.com; phone: +4722238880

Name

Croxx Med ApS

Responsibilities

sponsorDuties codes: 1,10,11,12,15 (Submission),5,6; contact email: bte@croxxmed.com; phone: +4520151221

Third parties

• {"country":"Denmark","full_name":"PharmaLex Denmark A/S","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Croxx Med ApS","duties_or_roles":"sponsorDuties codes: 1, 10, 11, 12, 15 (Submission), 5, 6","organisation_type":"Pharmaceutical company"}