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
2 other identifiers
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2019
CompletedFirst Submitted
Initial submission to the registry
June 14, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2021
CompletedMay 3, 2021
April 1, 2021
1.3 years
June 14, 2019
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular remodelling
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
From Visit2 (day 3) to visit 3 (day 90)
Secondary Outcomes (1)
Myocardial Salvage index (MSi)
Visit 2 (day 3)
Other Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
From baseline (Visit 1, day 1) to visit 3 (day 90)
Study Arms (2)
ATH3G10
EXPERIMENTALPhosphorylcholine human monoclonal antibody (ATH3G10)
Placebo
PLACEBO COMPARATORPlacebo to ATH3G10, 0.9% sodium chloride
Interventions
Eligibility Criteria
You may qualify if:
- Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
- Start of PCI less than 4 hours after symptom onset.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Uppsala University Hospital
Uppsala, 75237, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2019
First Posted
June 19, 2019
Study Start
March 29, 2019
Primary Completion
July 6, 2020
Study Completion
April 19, 2021
Last Updated
May 3, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share