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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03991143

Enrollment

Registered

2019-06-19

Start date

2019-03-29

Completion date

2021-04-19

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Elevation Myocardial Infarction

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.

Interventions

DRUGATH3G10

intravenous

DRUGPlacebo

intravenous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Myocardial Salvage index (MSi)	Visit 2 (day 3)	Effects on myocardial salvage index (MSi) measured by MRI

Other

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]	From baseline (Visit 1, day 1) to visit 3 (day 90)	Assessment of Safety and Tolerability based on incidence of AEs/SAEs

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026