Clinical Trials Directory

Trials / Completed

CompletedNCT03991143

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
82 (actual)
Sponsor
Athera Biotechnologies AB · Industry
Sex
All
Age
40 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGATH3G10intravenous
DRUGPlacebointravenous

Timeline

Start date
2019-03-29
Primary completion
2020-07-06
Completion
2021-04-19
First posted
2019-06-19
Last updated
2021-05-03

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03991143. Inclusion in this directory is not an endorsement.