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

Phase 2

Completed

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Drug: ATH3G10; Drug: Placebo

• Registration Number: NCT03991143
• Lead Sponsor: Athera Biotechnologies AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-29
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Primary Completion: 2020-07-06
• Status Verified: 2021-04
• Study Completion: 2021-04-19
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATH3G10	ATH3G10	Phosphorylcholine human monoclonal antibody (ATH3G10)
Placebo	Placebo	Placebo to ATH3G10, 0.9% sodium chloride

Primary Outcome Measures

Name	Time	Method
Left ventricular remodelling	From Visit2 (day 3) to visit 3 (day 90)	Change in Left Ventricular End-Diastolic Volume index (LV EDVi)

Secondary Outcome Measures

Name	Time	Method
Myocardial Salvage index (MSi)	Visit 2 (day 3)	Effects on myocardial salvage index (MSi) measured by MRI

Trial Locations

Locations (1)

Department of Cardiology, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden