Skip to main content
OpenTrials
Completed

NCT Number: NCT03991143

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Cardiology, Uppsala University Hospital

Uppsala, 75237, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATH3G10

Drug

intravenous

Other names: PC-mAB

Placebo

Drug

intravenous

Other names: 0.9% sodium chloride

Primary outcomes

  1. 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

  1. Myocardial Salvage index (MSi)

    Time frame: Visit 2 (day 3)

    Effects on myocardial salvage index (MSi) measured by MRI

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]

    Time frame: From baseline (Visit 1, day 1) to visit 3 (day 90)

    Assessment of Safety and Tolerability based on incidence of AEs/SAEs

Sponsors and collaborators

Lead sponsor

Athera Biotechnologies AB

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 19, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.