Acute Myocardial InfarctionPhase 2VCU-ART2NCT01175018
Anakinra to Prevent Adverse Post-infarction Remodeling (2)
A Phase 2 study testing Anakinra in people with Acute Myocardial Infarction and Heart Failure, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2012
- Phase
- Phase 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with STEMI will be asked to enroll according to the following inclusion criteria:
- age > 18 years,
- acute (<12 h) onset of chest pain associated with ST segment elevation (>2 mm) in 2 or more anatomically contiguous leads at ECG,
- and successful primary percutaneous coronary intervention.
Who cannot join
- inability to give informed consent,
- late presentation (>12 h),
- unsuccessful revascularization procedure,
- hemodynamic instability including hypotension,
- prior Q-wave AMI,
- end-stage congestive heart failure (American Heart Association [AHA]/American College of Cardiology [ACC] class C-D, New York Heart Association IV), severe left ventricular dysfunction (EF<20%),
Show all 10Show fewer
- severe valvular heart disease,
- pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic resonance imaging, coagulopathy (INR>1.5 or platelet count<50000/mm3),
- recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs),
- chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.
The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. The investigators propose that an antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory response and lead to a more favorable cardiac remodeling process.
Read the detailed description
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.
The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. Interleukin-1 (IL-1) is the prototypical inflammatory cytokine involved in the tissue response to injury. In the experimental model of large anterior wall AMI in the mouse, IL-1 blockade using anakinra, a recombinant human IL-1 receptor antagonist ameliorates cardiac remodeling and improves survival following AMI. Although the mouse AMI model is helpful in understanding the events leading to adverse post-infarction cardiac remodeling and heart failure, the exact role of IL-1 in patients with AMI has not been completely characterized. The investigators propose to address this question by studying patients presenting with ST-segment elevation AMI (STEMI). Such patients are at high risk for in-hospital and long-term mortality and display several markers of inflammation. The investigators hypothesize that IL-1 blockade in patients STEMI with will limit the acute inflammatory response and prevent adverse cardiac remodeling, heart failure, and related morbidity.
The investigators hypothesize that treatment with anakinra will lead to more favorable cardiac remodeling. Left ventricular end-systolic volume index (LVESVi) is the preferred clinical marker of adverse cardiac remodeling and a strong predictor of heart failure-related mortality in patients with STEMI, and will be used as primary endpoint of the study. The investigators propose that anakinra will reduce the change in LVESVi from baseline to 10-14 weeks after STEMI, and will prevent, at least in part, other changes in cardiac function and exercise tolerance associated with adverse cardiac remodeling and heart failure.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- Anakinra, Placebo
- Keywords
- Acute myocardial infarction, Heart Failure, Cardiac Remodeling
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Anakinra 100 mg s.c. daily for 14 days
PlaceboDrug
Also called NaCl 0.9%
0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Anakinra 100 mg injectable subcutaneously daily Receives: Drug: Anakinra |
| Placebo | Placebo comparator | 0.67 ml of sodium chloride (NaCl) 0.9% solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices
Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.
Measured: 10-14 weeks minus baseline
Secondary outcomes (15)
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
Measured: 10-14 weeks
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)
Measured: 10-14 weeks
Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks
Measured: 10-14 weeks
Incidence of Heart Failure
Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure
Measured: 10-14 weeks
Number of Adverse Events in Each Group
Measured: 10-14 weeks
Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)
Measured: 10-14 weeks
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
Measured: 10-14 weeks
Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks
Measured: 10-14 weeks
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)
Measured: 10-14 weeks
Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging
Measured: 10-14 weeks
Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)
Measured: 10-14 weeks
Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%
Measured: 10-14 weeks
Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%
Measured: 10-14 weeks
Number of Deaths in Each Group
Measured: 10-14 weeks
Number of Adverse Events Requiring Withdrawal in Each Group
Measured: 10-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionDec 2012
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 (6)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Antonio Abbate, M.D., Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175018
- Sponsor's protocol ID
- AHA 10SDG3030051
- Acronym
- VCU-ART2
- Status last verified
- May 2016
- First submitted
- 30 Jul 2010
- Last updated
- 23 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abbate A, Kontos MC, Grizzard JD, Biondi-Zoccai GG, Van Tassell BW, Robati R, Roach LM, Arena RA, Roberts CS, Varma A, Gelwix CC, Salloum FN, Hastillo A, Dinarello CA, Vetrovec GW; VCU-ART Investigators. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). Am J Cardiol. 2010 May 15;105(10):1371-1377.e1. doi: 10.1016/j.amjcard.2009.12.059. Epub 2010 Apr 2.
PubMed 20451681Abbate A, Van Tassell BW, Biondi-Zoccai G, Kontos MC, Grizzard JD, Spillman DW, Oddi C, Roberts CS, Melchior RD, Mueller GH, Abouzaki NA, Rengel LR, Varma A, Gambill ML, Falcao RA, Voelkel NF, Dinarello CA, Vetrovec GW. Effects of interleukin-1 blockade with anakinra on adverse cardiac remodeling and heart failure after acute myocardial infarction [from the Virginia Commonwealth University-Anakinra Remodeling Trial (2) (VCU-ART2) pilot study]. Am J Cardiol. 2013 May 15;111(10):1394-400. doi: 10.1016/j.amjcard.2013.01.287. Epub 2013 Feb 27.
PubMed 23453459Denicolai M, Morello M, Golino M, Corna G, Del Buono MG, Agatiello CR, Van Tassell BW, Abbate A. Interleukin-1 Blockade in Patients With ST-Segment Elevation Myocardial Infarction Across the Spectrum of Coronary Artery Disease Complexity. J Cardiovasc Pharmacol. 2025 Mar 1;85(3):200-210. doi: 10.1097/FJC.0000000000001652.
PubMed 39531530Abbate A, Kontos MC, Abouzaki NA, Melchior RD, Thomas C, Van Tassell BW, Oddi C, Carbone S, Trankle CR, Roberts CS, Mueller GH, Gambill ML, Christopher S, Markley R, Vetrovec GW, Dinarello CA, Biondi-Zoccai G. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies). Am J Cardiol. 2015 Feb 1;115(3):288-92. doi: 10.1016/j.amjcard.2014.11.003. Epub 2014 Nov 13.
PubMed 25482680Sonnino C, Christopher S, Oddi C, Toldo S, Falcao RA, Melchior RD, Mueller GH, Abouzaki NA, Varma A, Gambill ML, Van Tassell BW, Dinarello CA, Abbate A. Leukocyte activity in patients with ST-segment elevation acute myocardial infarction treated with anakinra. Mol Med. 2014 Nov 18;20(1):486-9. doi: 10.2119/molmed.2014.00121.
PubMed 25121719Falcao RA, Christopher S, Oddi C, Reznikov L, Grizzard JD, Abouzaki NA, Varma A, Van Tassell BW, Dinarello CA, Abbate A. Interleukin-10 in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2014 Mar 1;172(1):e6-8. doi: 10.1016/j.ijcard.2013.12.126. Epub 2014 Jan 5. No abstract available.
PubMed 24467979
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anakinra to Prevent Adverse Post-infarction Remodeling (2)
- ClinicalTrials.gov ID
- NCT01175018
- Acronym / sponsor ID
- VCU-ART2 / AHA 10SDG3030051
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Keywords
- Acute myocardial infarction, Heart Failure, Cardiac Remodeling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Posted 23 May 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 (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.
The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. The investigators propose that an antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory response and lead to a more favorable cardiac remodeling process.
Detailed description
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.
The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. Interleukin-1 (IL-1) is the prototypical inflammatory cytokine involved in the tissue response to injury. In the experimental model of large anterior wall AMI in the mouse, IL-1 blockade using anakinra, a recombinant human IL-1 receptor antagonist ameliorates cardiac remodeling and improves survival following AMI. Although the mouse AMI model is helpful in understanding the events leading to adverse post-infarction cardiac remodeling and heart failure, the exact role of IL-1 in patients with AMI has not been completely characterized. The investigators propose to address this question by studying patients presenting with ST-segment elevation AMI (STEMI). Such patients are at high risk for in-hospital and long-term mortality and display several markers of inflammation. The investigators hypothesize that IL-1 blockade in patients STEMI with will limit the acute inflammatory response and prevent adverse cardiac remodeling, heart failure, and related morbidity.
The investigators hypothesize that treatment with anakinra will lead to more favorable cardiac remodeling. Left ventricular end-systolic volume index (LVESVi) is the preferred clinical marker of adverse cardiac remodeling and a strong predictor of heart failure-related mortality in patients with STEMI, and will be used as primary endpoint of the study. The investigators propose that anakinra will reduce the change in LVESVi from baseline to 10-14 weeks after STEMI, and will prevent, at least in part, other changes in cardiac function and exercise tolerance associated with adverse cardiac remodeling and heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: AnakinraAnakinra 100 mg injectable subcutaneously daily |
| Placebo | Placebo comparator | Drug: Placebo0.67 ml of sodium chloride (NaCl) 0.9% solution |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with STEMI will be asked to enroll according to the following inclusion criteria:
Key exclusion criteria (10 listed)
- inability to give informed consent,
- late presentation (>12 h),
- unsuccessful revascularization procedure,
- hemodynamic instability including hypotension,
- prior Q-wave AMI,
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 |
|---|---|---|
| AnakinraAlso: KineretAnakinra 100 mg s.c. daily for 14 days | Drug | Anakinra |
| PlaceboAlso: NaCl 0.9%0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days | Drug | Placebo |
Primary outcome
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices
Time frame: 10-14 weeks minus baseline
Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.
15 secondary outcomes
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
Time frame: 10-14 weeks
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)
Time frame: 10-14 weeks
Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks
Time frame: 10-14 weeks
Incidence of Heart Failure
Time frame: 10-14 weeks
Number of Adverse Events in Each Group
Time frame: 10-14 weeks
Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)
Time frame: 10-14 weeks
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
Time frame: 10-14 weeks
Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks
Time frame: 10-14 weeks
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)
Time frame: 10-14 weeks
Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging
Time frame: 10-14 weeks
Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)
Time frame: 10-14 weeks
Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%
Time frame: 10-14 weeks
Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%
Time frame: 10-14 weeks
Number of Deaths in Each Group
Time frame: 10-14 weeks
Number of Adverse Events Requiring Withdrawal in Each Group
Time frame: 10-14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20451681Abbate A, Kontos MC, Grizzard JD, Biondi-Zoccai GG, Van Tassell BW, Robati R, Roach LM, Arena RA, Roberts CS, Varma A, Gelwix CC, Salloum FN, Hastillo A, Dinarello CA, Vetrovec GW; VCU-ART Investigators. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). Am J Cardiol. 2010 May 15;105(10):1371-1377.e1. doi: 10.1016/j.amjcard.2009.12.059. Epub 2010 Apr 2.
- Results publication: PubMed 23453459Abbate A, Van Tassell BW, Biondi-Zoccai G, Kontos MC, Grizzard JD, Spillman DW, Oddi C, Roberts CS, Melchior RD, Mueller GH, Abouzaki NA, Rengel LR, Varma A, Gambill ML, Falcao RA, Voelkel NF, Dinarello CA, Vetrovec GW. Effects of interleukin-1 blockade with anakinra on adverse cardiac remodeling and heart failure after acute myocardial infarction [from the Virginia Commonwealth University-Anakinra Remodeling Trial (2) (VCU-ART2) pilot study]. Am J Cardiol. 2013 May 15;111(10):1394-400. doi: 10.1016/j.amjcard.2013.01.287. Epub 2013 Feb 27.
- Derived from this study: PubMed 39531530Denicolai M, Morello M, Golino M, Corna G, Del Buono MG, Agatiello CR, Van Tassell BW, Abbate A. Interleukin-1 Blockade in Patients With ST-Segment Elevation Myocardial Infarction Across the Spectrum of Coronary Artery Disease Complexity. J Cardiovasc Pharmacol. 2025 Mar 1;85(3):200-210. doi: 10.1097/FJC.0000000000001652.
- Derived from this study: PubMed 25482680Abbate A, Kontos MC, Abouzaki NA, Melchior RD, Thomas C, Van Tassell BW, Oddi C, Carbone S, Trankle CR, Roberts CS, Mueller GH, Gambill ML, Christopher S, Markley R, Vetrovec GW, Dinarello CA, Biondi-Zoccai G. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies). Am J Cardiol. 2015 Feb 1;115(3):288-92. doi: 10.1016/j.amjcard.2014.11.003. Epub 2014 Nov 13.
- Derived from this study: PubMed 25121719Sonnino C, Christopher S, Oddi C, Toldo S, Falcao RA, Melchior RD, Mueller GH, Abouzaki NA, Varma A, Gambill ML, Van Tassell BW, Dinarello CA, Abbate A. Leukocyte activity in patients with ST-segment elevation acute myocardial infarction treated with anakinra. Mol Med. 2014 Nov 18;20(1):486-9. doi: 10.2119/molmed.2014.00121.
- Derived from this study: PubMed 24467979Falcao RA, Christopher S, Oddi C, Reznikov L, Grizzard JD, Abouzaki NA, Varma A, Van Tassell BW, Dinarello CA, Abbate A. Interleukin-10 in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2014 Mar 1;172(1):e6-8. doi: 10.1016/j.ijcard.2013.12.126. Epub 2014 Jan 5. No abstract available.
- VCU Pauley Heart CenterLink provided by the sponsor.
- 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.
Antonio Abbate, M.D., Ph.D. 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 2 study testing Anakinra in people with Acute Myocardial Infarction and Heart Failure, 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 4 inclusion and 10 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 23 May 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. 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?
Yes. Results are posted in the registry (first posted 23 May 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?
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices (time frame: 10-14 weeks minus baseline). 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 NCT01175018, which also lists 6 linked publications.
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 23 May 2016.