ST Elevation Myocardial InfarctionPhase 2NCT03991143
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction
A Phase 2 study testing ATH3G10 in people with ST Elevation Myocardial Infarction, run by Athera Biotechnologies AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- ATH3G10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteSweden
- Study dates
- 29 Mar 2019to 19 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
- Start of PCI less than 4 hours after symptom onset.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology, Uppsala University Hospital
Uppsala, 75237
About this study
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
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.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- ATH3G10, Placebo
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH3G10Drug
Also called PC-mAB
intravenous
PlaceboDrug
Also called 0.9% sodium chloride
intravenous
| Study group | Role | What they receive |
|---|---|---|
| ATH3G10 | Experimental | Phosphorylcholine human monoclonal antibody (ATH3G10) Receives: Drug: ATH3G10 |
| Placebo | Placebo comparator | Placebo to ATH3G10, 0.9% sodium chloride Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular remodelling
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
Measured: From Visit2 (day 3) to visit 3 (day 90)
Secondary outcomes (1)
Myocardial Salvage index (MSi)
Effects on myocardial salvage index (MSi) measured by MRI
Measured: Visit 2 (day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start29 Mar 2019
- Primary completion6 Jul 2020
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athera Biotechnologies AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991143
- Sponsor's protocol ID
- ATH3G10-006
- Other IDs
- 2018-003676-12, 2018
- Status last verified
- Apr 2021
- First submitted
- 14 Jun 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03991143
- Acronym / sponsor ID
- ATH3G10-006
- Conditions
- ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Athera Biotechnologies ABIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATH3G10 | Experimental | Drug: ATH3G10Phosphorylcholine human monoclonal antibody (ATH3G10) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to ATH3G10, 0.9% sodium chloride |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
- Start of PCI less than 4 hours after symptom onset.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATH3G10Also: PC-mABintravenous | Drug | ATH3G10 |
| PlaceboAlso: 0.9% sodium chlorideintravenous | Drug | Placebo |
Primary outcome
Left ventricular remodelling
Time frame: From Visit2 (day 3) to visit 3 (day 90)
Change in Left Ventricular End-Diastolic Volume index (LV EDVi)
1 secondary outcome
Myocardial Salvage index (MSi)
Time frame: Visit 2 (day 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATH3G10 in people with ST Elevation Myocardial Infarction, run by Athera Biotechnologies AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular remodelling (time frame: From Visit2 (day 3) to visit 3 (day 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.