Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction

Athera Biotechnologies AB82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

ST Elevation Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Left ventricular remodelling

Change in Left Ventricular End-Diastolic Volume index (LV EDVi)

Time frame: From Visit2 (day 3) to visit 3 (day 90)

Secondary Outcomes

Myocardial Salvage index (MSi)

Effects on myocardial salvage index (MSi) measured by MRI

Time frame: Visit 2 (day 3)