In short
A new clinical trial is underway to investigate the potential benefits of RTP-026 Sodium, a drug designed to help patients with ST-Elevation Myocardial Infarction (STEMI). This exploratory study aims to assess the safety, tolerability, and effectiveness of RTP-026 compared to a placebo in multiple doses. The trial involves patients who have experienced acute chest pain and meet specific criteria for STEMI diagnosis.
At a glance
- Drug Name
- RTP-026 Sodium
- Condition Studied
- ST-Elevation Myocardial Infarction (STEMI)
- Study Type
- Exploratory, randomized, double-blind, multicentre, placebo-controlled
- Primary Objectives
- Evaluate safety, tolerability, and efficacy of RTP-026 against placebo
- Key Inclusion Criteria
- - Men 18-80 years, post-menopausal women up to 80 years; - Acute chest pain < 12 hours; - STEMI on ECG; - Eligible for primary PCI
- Key Exclusion Criteria
- - Participation in other studies; - Previous exposure to RTP-026; - Time from symptoms to PCI > 12 hours; - Active malignant disease
- Primary Endpoints
- - Safety and tolerability assessment; - Changes in cardiac markers (cTnT and CK-MB)
- Secondary Endpoints
- - Myocardial Salvage Index (MSI); - Infarct Size (IS); - Left Ventricular Ejection Fraction (LVEF); - Major Adverse Cardiac Events (MACE)
- Drug Administration
- Intravenous infusion, max dose 0.68 mg/kg, treatment period 1 day
What is RTP-026?
RTP-026 SODIUM is an investigational drug being studied for the treatment of patients with ST-Elevation Myocardial Infarction (STEMI). It is a protein-based solution that is given through intravenous infusion (directly into a vein). The drug is currently being tested in clinical trials to determine its safety and effectiveness in treating STEMI patients.
Medical Condition: ST-Elevation Myocardial Infarction (STEMI)
ST-Elevation Myocardial Infarction (STEMI) is a severe type of heart attack. In medical terms, it's classified as an acute myocardial infarction. This condition occurs when a coronary artery (a blood vessel that supplies blood to the heart) becomes completely blocked, causing part of the heart muscle to die due to lack of blood flow. The "ST-elevation" refers to a specific pattern seen on an electrocardiogram (ECG), which is a test that measures the electrical activity of the heart.
Study Objectives
The main objectives of the study on RTP-026 are:
- Safety and Tolerability: To evaluate how safe RTP-026 is compared to a placebo (a substance with no active ingredients) when given in multiple doses.
- Efficacy: To determine how effective RTP-026 is compared to a placebo when given in multiple doses.
Who Can Participate in the Study?
The study has specific criteria for who can participate. These include:
- Men between 18-80 years old and post-menopausal women up to 80 years old
- Patients experiencing acute chest pain for less than 12 hours
- Patients diagnosed with STEMI based on specific ECG criteria
- Patients eligible for primary PCI (Percutaneous Coronary Intervention, a procedure to open blocked arteries in the heart)
- Patients with a specific range of NLR (Neutrophil-to-Lymphocyte Ratio, a blood test marker) at hospital admission or after PCI
Who Cannot Participate in the Study?
Certain conditions may prevent a person from participating in the study. These include:
- Participation in other studies involving investigational drugs within 4 weeks before this study
- Previous exposure to RTP-026
- More than 12 hours have passed since symptom onset before primary PCI
- Active cancer (except for certain skin cancers)
- Ongoing treatment with immune-suppressive medications
- Conditions that might prevent compliance with the study protocol (e.g., psychiatric disorders, dementia)
- Known contraindications to CMR (Cardiac Magnetic Resonance imaging)
- High risk score on a specific heart attack risk assessment tool
How the Drug is Administered
RTP-026 SODIUM is given as a solution for intravenous infusion. This means the drug is delivered directly into the patient's bloodstream through a vein. The maximum daily dose is 0.68 mg per kilogram of body weight, and the treatment period is expected to last for one day.
What the Study Will Measure
The study will look at several factors to determine the safety and effectiveness of RTP-026. These include:
- Safety measures: This includes monitoring for side effects, changes in vital signs, ECG readings, and laboratory test results.
- Heart damage markers: The study will measure changes in specific proteins in the blood that indicate heart muscle damage.
- Heart function: Using special imaging techniques (CMR), the study will assess how much of the heart muscle was affected by the heart attack and how well the heart is functioning.
- Inflammation and stress markers: The study will measure various substances in the blood that indicate inflammation and heart stress.
- Clinical outcomes: The researchers will track events such as death, recurrent heart attacks, or heart failure requiring hospital admission.
- Length of hospital stay: The study will record how long patients need to stay in the hospital.
This comprehensive evaluation will help determine if RTP-026 SODIUM is safe and effective for treating patients with ST-Elevation Myocardial Infarction (STEMI).