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出境医 / 临床实验 / Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction

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

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.


Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: ATH3G10 Drug: Placebo Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2019
Actual Primary Completion Date : July 6, 2020
Actual Study Completion Date : April 19, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: ATH3G10
Phosphorylcholine human monoclonal antibody (ATH3G10)
 Drug: ATH3G10
intravenous
Other Name: PC-mAB
Placebo Comparator: Placebo
Placebo to ATH3G10, 0.9% sodium chloride
 Drug: Placebo
intravenous
Other Name: 0.9% sodium chloride
Outcome Measures
Primary Outcome Measures :
  1. Left ventricular remodelling [ Time Frame: From Visit2 (day 3) to visit 3 (day 90) ]
    Change in Left Ventricular End-Diastolic Volume index (LV EDVi)


Secondary Outcome Measures :
  1. Myocardial Salvage index (MSi) [ Time Frame: Visit 2 (day 3) ]
    Effects on myocardial salvage index (MSi) measured by MRI


Other Outcome Measures:
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Sweden
Department of Cardiology, Uppsala University Hospital
Uppsala, Sweden, 75237
Sponsors and Collaborators
Athera Biotechnologies AB
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE March 29, 2019
Actual Primary Completion Date July 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		Left ventricular remodelling [ Time Frame: From Visit2 (day 3) to visit 3 (day 90) ]
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		Myocardial Salvage index (MSi) [ Time Frame: Visit 2 (day 3) ]
Effects on myocardial salvage index (MSi) measured by MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2019) 		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
Original Other Pre-specified Outcome Measures
 (submitted: June 18, 2019) 		Safety and tolerability [ Time Frame: From baseline (Visit 1, day 1) to visit 3 (day 90) ]
Safety and tolerability: incidence of AEs/SAEs
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ST Elevation Myocardial Infarction
Intervention  ICMJE
  • Drug: ATH3G10
    intravenous
    Other Name: PC-mAB
  • Drug: Placebo
    intravenous
    Other Name: 0.9% sodium chloride
Study Arms  ICMJE
  • Experimental: ATH3G10
    Phosphorylcholine human monoclonal antibody (ATH3G10)
    Intervention: Drug: ATH3G10
  • Placebo Comparator: Placebo
    Placebo to ATH3G10, 0.9% sodium chloride
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2020) 		82
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		80
Actual Study Completion Date  ICMJE April 19, 2021
Actual Primary Completion Date July 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991143
Other Study ID Numbers  ICMJE ATH3G10-006
2018-003676-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Athera Biotechnologies AB
Study Sponsor  ICMJE Athera Biotechnologies AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Athera Biotechnologies AB
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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