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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
ATH3G10
Placebo
Sponsored by
Athera Biotechnologies AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Cardiology, Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ATH3G10

Placebo

Arm Description

Phosphorylcholine human monoclonal antibody (ATH3G10)

Placebo to ATH3G10, 0.9% sodium chloride

Outcomes

Primary Outcome Measures

Left ventricular remodelling
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)

Secondary Outcome Measures

Myocardial Salvage index (MSi)
Effects on myocardial salvage index (MSi) measured by MRI

Full Information

First Posted
June 14, 2019
Last Updated
April 30, 2021
Sponsor
Athera Biotechnologies AB
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1. Study Identification

Unique Protocol Identification Number
NCT03991143
Brief Title
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
July 6, 2020 (Actual)
Study Completion Date
April 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athera Biotechnologies AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATH3G10
Arm Type
Experimental
Arm Description
Phosphorylcholine human monoclonal antibody (ATH3G10)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to ATH3G10, 0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
ATH3G10
Other Intervention Name(s)
PC-mAB
Intervention Description
intravenous
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
Left ventricular remodelling
Description
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
Time Frame
From Visit2 (day 3) to visit 3 (day 90)
Secondary Outcome Measure Information:
Title
Myocardial Salvage index (MSi)
Description
Effects on myocardial salvage index (MSi) measured by MRI
Time Frame
Visit 2 (day 3)
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Description
Assessment of Safety and Tolerability based on incidence of AEs/SAEs
Time Frame
From baseline (Visit 1, day 1) to visit 3 (day 90)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Cardiology, Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75237
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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