Acute Myocardial InfarctionPhase 1/2VCU-Alpha1RTNCT01936896
Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
A Phase 1/2 study testing Alpha 1-Antitrypsin in people with Acute Myocardial Infarction, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Acute myocardial infarction is characterized by an intense inflammatory response. The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Alpha 1-Antitrypsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
- Planned or completed coronary angiogram for potential intervention
- Age>21
Who cannot join
- Inability to give informed consent
- Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
- Pregnancy
- Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
- Preexisting severe left ventricular dysfunction (EF<20%)
- Preexisting severe valvular heart disease
Show all 13Show fewer
- Known active infections (acute or chronic)
- Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
- Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
- Known active malignancy of any type, or prior diagnosis in the past 10 years
- Anticipated need for cardiac or major surgery
- Known active cancer (or prior diagnosis of cancer within the past 10 years)
- Known Immunoglobulin A (IgA) deficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction
Acute myocardial infarction is characterized by an intense inflammatory response.
The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).
- Conditions
- Acute Myocardial Infarction
- Being tested
- Alpha 1-Antitrypsin
- Keywords
- Acute myocardial infarction, Heart Failure, Inflammation
- Medical subject headings
- Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha 1-AntitrypsinDrug
Also called Prolastin C, Aralast NP
| Study group | Role | What they receive |
|---|---|---|
| Alpha-1 anti-trypsin (AAT) | Experimental | We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI) Receives: Drug: Alpha 1-Antitrypsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reactive Protein (Area Under the Curve)
A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.
Measured: 14 days
Secondary outcomes (1)
Left Ventricular End-systolic Volume Change
We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Abbate, MD, PhD, Principal investigator, Virginia Commonwealth UniversityBenjamin Van Tassell, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936896
- Sponsor's protocol ID
- HM15342
- Acronym
- VCU-Alpha1RT
- Status last verified
- Jan 2016
- First submitted
- 30 Aug 2013
- Last updated
- 12 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Abouzaki NA, Christopher S, Trankle C, Van Tassell BW, Carbone S, Mauro AG, Buckley L, Toldo S, Abbate A. Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-alpha1RT Study. J Cardiovasc Pharmacol. 2018 Jun;71(6):375-379. doi: 10.1097/FJC.0000000000000583.
PubMed 29634656
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01936896
- Acronym / sponsor ID
- VCU-Alpha1RT / HM15342
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Heart Failure, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 12 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myocardial infarction is characterized by an intense inflammatory response.
The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha-1 anti-trypsin (AAT) | Experimental | Drug: Alpha 1-AntitrypsinWe will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
- Planned or completed coronary angiogram for potential intervention
- Age>21
Key exclusion criteria (13 listed)
- Inability to give informed consent
- Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
- Pregnancy
- Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
- Preexisting severe left ventricular dysfunction (EF<20%)
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 |
|---|---|---|
| Alpha 1-AntitrypsinAlso: Prolastin C, Aralast NP | Drug | Alpha-1 anti-trypsin (AAT) |
Primary outcome
C Reactive Protein (Area Under the Curve)
Time frame: 14 days
A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.
1 secondary outcome
Left Ventricular End-systolic Volume Change
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29634656Abouzaki NA, Christopher S, Trankle C, Van Tassell BW, Carbone S, Mauro AG, Buckley L, Toldo S, Abbate A. Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-alpha1RT Study. J Cardiovasc Pharmacol. 2018 Jun;71(6):375-379. doi: 10.1097/FJC.0000000000000583.
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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.
Antonio Abbate, MD, PhD principal investigator
Virginia Commonwealth University
Benjamin Van Tassell, PharmD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alpha 1-Antitrypsin in people with Acute Myocardial Infarction, run by Virginia Commonwealth University at 1 site in United States.
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 3 inclusion and 13 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 12 Feb 2016. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
C Reactive Protein (Area Under the Curve) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936896, which also lists 1 linked publication.
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 12 Feb 2016.