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

ST Elevation Myocardial Infarction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991143
• Other study ID #: ATH3G10-006
• Secondary ID: 2018-003676-12
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2019
• Est. completion date: April 19, 2021

Study information

• Verified date: April 2021
• Source: Athera Biotechnologies AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 19, 2021
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• ATH3G10
intravenous
• Placebo
intravenous

Locations

Country	Name	City	State
Sweden	Department of Cardiology, Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Athera Biotechnologies AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]	Assessment of Safety and Tolerability based on incidence of AEs/SAEs	From baseline (Visit 1, day 1) to visit 3 (day 90)
Primary	Left ventricular remodelling	Change in Left Ventricular End-Diastolic Volume index (LV EDVi)	From Visit2 (day 3) to visit 3 (day 90)
Secondary	Myocardial Salvage index (MSi)	Effects on myocardial salvage index (MSi) measured by MRI	Visit 2 (day 3)