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

April 30, 2021 updated by: Athera Biotechnologies AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75237
        • Department of Cardiology, Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ATH3G10
Phosphorylcholine human monoclonal antibody (ATH3G10)
Drug: ATH3G10
intravenous
Other Names:
  • PC-mAB
PLACEBO_COMPARATOR: Placebo
Placebo to ATH3G10, 0.9% sodium chloride
Drug: Placebo
intravenous
Other Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline (Visit 1, day 1) to visit 3 (day 90)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Athera Biotechnologies AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2019

Primary Completion (ACTUAL)

July 6, 2020

Study Completion (ACTUAL)

April 19, 2021

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (ACTUAL)

June 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATH3G10-006
  • 2018-003676-12 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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