A Phase IIa, Placebo-controlled, Double Blind, Randomised Multicentre Pilot Study to Investigate the Efficacy, Safety and Tolerability of the Monoclonal Antibody ATH3G10 in Patients With ST-elevation Myocardial Infarction
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Athera Biotechnologies AB
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Left ventricular remodelling
Study Overview
Brief Summary
Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling.
This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
- •Start of PCI less than 4 hours after symptom onset.
Exclusion Criteria
- •Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema.
- •Previous major vascular intervention within the last 4 weeks.
- •History of an infarct in the same artery that is currently affected.
- •Conditions contraindicating MRI
Arms & Interventions
ATH3G10
Phosphorylcholine human monoclonal antibody (ATH3G10)
Intervention: ATH3G10 (Drug)
Placebo
Placebo to ATH3G10, 0.9% sodium chloride
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Left ventricular remodelling
Time Frame: From Visit2 (day 3) to visit 3 (day 90)
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
Secondary Outcomes
- Myocardial Salvage index (MSi)(Visit 2 (day 3))