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

NCT ID: NCT03991143

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-29

Study Completion Date

2021-04-19

Brief Summary

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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.

Detailed Description

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Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ATH3G10

Phosphorylcholine human monoclonal antibody (ATH3G10)

Group Type EXPERIMENTAL

ATH3G10

Intervention Type DRUG

intravenous

Placebo

Placebo to ATH3G10, 0.9% sodium chloride

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intravenous

Interventions

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ATH3G10

intravenous

Intervention Type DRUG

Placebo

intravenous

Intervention Type DRUG

Other Intervention Names

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PC-mAB 0.9% sodium chloride

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Athera Biotechnologies AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Cardiology, Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2018-003676-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ATH3G10-006

Identifier Type: -

Identifier Source: org_study_id

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