Placebo-controlled, double blind, randomised research in several centres to investigate the effect, safety and tolerability of a monoclonal antibody in patients with severe acute myocardial infarction.

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003676-12-SE
• Lead Sponsor: Athera Biotechnologies AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;<br> Secondary Objective: To investigate effects on myocardial salvage index (MSi) measured by MRI<br> To investigate the safety and tolerability of ATH3G10 <br> <br> ;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 Outcome Measures

Name	Time	Method
<br> Secondary end point(s): •Safety and tolerability: AEs/SAEs, blood pressure, physical examination, ECG and laboratory assessments including clinical chemistry, haematology and coagulation. <br> •Myocardial Salvage index (MSi) at Visit 2.<br> ;Timepoint(s) of evaluation of this end point: At V3 (3 month post IMP administration)