Treatment of ST-elevated myocardial infarction (STEMI) after percutaneous intervention (PCI) MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: ATH3G10
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATH3G10
Current Sponsor code: ATH3G10
Other descriptive name: 3G10
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Norrtälje Sjukhus, Tiohundra AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Symptoms and signs consistent with acute MI and ST elevation at the J-point in two contiguous leads (cut-points: >0.2mV in men and >0.15 mV in women in leads V2-V3 and/or >0.1 mV in other leads) 3. Start of PCI, defined as when the guide wire is passed through the stenosis, less than 4 hours after symptom onset. Symptom onset defined as the time of the start of the pain that causes the call to the ambulance. 4. TIMI flow grade 0 at angiography before PCI in left anterior descending coronary artery segment 6 or 7 without collaterals OR TIMI flow grade less than 3 in any infarct related main coronary arteries after PCI. 5. Age 40-85, inclusive Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Cardiogenic chock, non-compensated acute heart failure and/or pulmonary oedema. 2. Previous major vascular intervention within the last 4 weeks. 3. History of an infarct in the same artery that is currently affected. 4. Thrombolysis therapy prior to admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal of this study is to evaluate efficacy of a single administration of ATH3G10 in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).;Secondary Objective: To investigate effects on myocardial salvage index (MSi) measured by MRI To investigate the safety and tolerability of ATH3G10 ;Primary end point(s): Left Ventricular End-Diastolic Volume index (LV EDVi) change from Visit 2 to Visit 3;Timepoint(s) of evaluation of this end point: At V3 (3 month post IMP administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety and tolerability: AEs/SAEs, blood pressure, physical examination, ECG and laboratory assessments including clinical chemistry, haematology and coagulation. • Myocardial Salvage index (MSi) at Visit 2. ;Timepoint(s) of evaluation of this end point: At V3 (3 month post IMP administration) | — |
Countries
Denmark, Netherlands, Sweden
Contacts
Public ContactCEO
Athera Biotechnologies AB
Outcome results
None listed