Coronary Artery Bypass GraftingPhase 3LEVO-CTSNCT02025621
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A Phase 3 study testing Levosimendan in people with Coronary Artery Bypass Grafting and Mitral Valve Surgery, run by Tenax Therapeutics, Inc. at 60 sites in 2 countries.
Trial summary
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- What is being tested?
- Levosimendan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 882 participants
- Where
- 60 sitesin 2 countries
- Study dates
- Jul 2014to Nov 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery.
- Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with mitral valve surgery, or 4) mitral valve surgery with or without other valves
- Surgery will employ CPB pump
- Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.
- Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours before surgery.
- Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration).
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2.
- Weight ≥ 170 kg.
- Patients whose SBP cannot be managed to ensure SBP > 90 mmHg at initiation of study drug.
Show all 19Show fewer
- Heart rate ≥ 120 bpm, persistent for at least 10 minutes screening and unresponsive to treatment.
- Hemoglobin < 80 g/L.
- Serum potassium < 3.5 mmol/L and > 5.5 mmol/L at baseline.
- A history of Torsades de Pointes.
- Mechanical assist device (IABP, LVAD, ECMO) in the patient at the start of surgery or pre-planned to be inserted during surgery before coming off CPB.
- Patients with aortal femoral occlusive disease that would prohibit use of IABP unless VAD or ECMO not available.
- Liver dysfunction Child Pugh Class B or C
- Patients having severely compromised immune function
- Pregnant, suspected to be pregnant, or breast-feeding.
- Received an experimental drug or used an experimental medical device in previous 30 days.
- Known allergic reaction or sensitivity to Levosimendan or excipients.
- Received commercial Levosimendan within 30 days before the planned start of study drug.
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Trial locations and contacts
60 sites in 2 countries.
60 sites in 2 countries
United States49 sites
St. Peter's Hospital
Albany, New York
Lehigh Valley Hospital
Allentown, Pennsylvania
St. Joseph's Mercy Hospital
Ann Arbor, Michigan
Mission Hospital
Asheville, North Carolina
Boca Raton Community Hospital
Boca Raton, Florida
Brigham and Women's Hospital
Boston, Massachusetts
Tufts Medical Center
Boston, Massachusetts
University of Alabama at Burlington Hospital
Burlington, Alabama
University of Virginia Health System
Charlottesville, Virginia
The Christ's Hospital; Lindner Clinical Trial Center
Cincinnati, Ohio
Case Medical Center
Cleveland, Ohio
Cleveland Clinic
Cleveland, Ohio
Ohio State University Hospital
Columbus, Ohio
Baylor Hospital
Dallas, Texas
Oakwood Hospital and Medical Center
Dearborn, Michigan
Northwestern University Hospital
Evanston, Illinois
Lutheran Hospital of Indiana
Fort Wayne, Indiana
Shands Hospital at the University of Florida
Gainesville, Florida
Spectrum Health
Grand Rapids, Michigan
Moses H. Cone Memorial Hospital
Greensboro, North Carolina
Hartford Hospital
Hartford, Connecticut
Huntsville Hospital
Huntsville, Alabama
Franciscan St. Francis Health
Indianapolis, Indiana
St. Luke's Hospital
Kansas City, Missouri
Nebraska Heart Institute
Lincoln, Nebraska
University of Louisville Hospital
Louisville, Kentucky
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin
Morristown Medical Center
Morristown, New Jersey
St. Thomas Heart
Nashville, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee
Yale-New Haven Hospital
New Haven, Connecticut
Columbia University Medical Center
New York, New York
Lenox Hill Hospital
New York, New York
Mount Sinai Medical Center
New York, New York
Oklahoma Heart Hospital
Oklahoma City, Oklahoma
Nebraska Medical Center
Omaha, Nebraska
The Heart Hospital Baylor Plano
Plano, Texas
Maine Medical Center
Portland, Maine
Duke University Hospital
Raleigh, North Carolina
Redmond Regional Medical Center
Rome, Georgia
Saint Francis Hospital/The Heart Center
Roslyn, New York
Mercy General Hospital
Sacramento, California
University of California San Diego Medical Center
San Diego, California
Barnes Jewish Hospital
St Louis, Missouri
Stanford University School of Medicine
Stanford, California
Franciscan Health System Res. Center
Tacoma, Washington
Tampa General Hospital
Tampa, Florida
ProMedica Toledo Hospital
Toledo, Ohio
Iowa Heart Center/ Mercy Medical Center
West Des Moines, Iowa
Canada11 sites
University of Alberta Hospital
Edmonton, Alberta
Hamilton Health Sciences
Hamilton, Ontario
London Health Sciences Center, University Hospital
London, Ontario
McGill University Health Centre-Royal Victoria Hospital
Montreal, Quebec
Montreal Heart Institute
Montreal, Quebec
Southlake Regional Health Center
Newmarket, Ontario
Institute universitaire de cardiologie et pneumologie de Quebec
Québec
St. Michael's Hospital
Toronto, Ontario
Royal Jubilee Hospital (Vancouver Island Health Authority)
Victoria, British Columbia
Victoria Heart Institute Foundation
Victoria, British Columbia
St. Boniface Hospital
Winnepeg, Manitoba
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).
Read the detailed description
This study is being done to evaluate the efficacy of levosimendan compared with placebo in reducing the co-primary endpoints of 30-day composite of all-cause death or use of mechanical assist device (IABP, LVAD or ECMO) or the composite event rate of all-cause death, perioperative MI, need for dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on CPB.
- Being tested
- Levosimendan, Placebo
- Keywords
- coronary artery bypass grafting, CABG, mitral valve, LCOS, low cardiac output syndrome, levosimendan
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Also called Simdax
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dual Efficacy Endpoint Events
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Measured: 30 days
Number of Quad Efficacy Endpoint Events
Composite of all-cause death (at 30 days), or perioperative nonfatal MI [CK-MB >10xULN or >100 ng/mL, CK-MB >5xULN or 50 ng/mL with new Q wave (>0.04 seconds wide in two contiguous leads) or new left bundle branch block)] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
Measured: 30 days
Secondary outcomes (3)
Duration of Intensive Care Unit/Critical or Coronary Care Unit (ICU/CCU) (Days)
Duration of intensive care unit/critical or coronary care unit (ICU/CCU) length of stay (LOS) in days
Measured: participants will be followed for during the participant's hospital stay up to 30 days
Incidence of Low Cardiac Output Syndrome (LCOS)
Use of a mechanical cardiac assist device within 5 days after surgery, two consecutive measurements of low cardiac output (defined as a cardiac output of ≤2.0 liters per minute per square meter of bodysurface area), one measurement of low cardiac output plus the use of two or more inotropes at or beyond 24 hours after surgery, or the use of two or more inotropes at or beyond 24 hours after surgery with the indicated reason being low cardiac output.
Measured: 5 days
Postoperative Use of Secondary Inotrope
Use of (dobutamine, milrinone, epinephrine, dopamine) associated with index surgical procedure at 24 hours after initiation of surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2016
- Study completionNov 2016
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 (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenax Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajendra Mehta, MD, Principal investigator, Duke Clinical Research InstituteJohn Alexander, MD, Study chair, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025621
- Sponsor's protocol ID
- TNX-LVO-01
- Acronym
- LEVO-CTS
- Status last verified
- May 2018
- First submitted
- 18 Dec 2013
- Last updated
- 21 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Verma S, Rathwell S, Fremes S, Zheng Y, Mehta R, Lopes RD, Alexander JH, Goodman SG, Diepen SV; LEVO-CTS investigators. Associated factors and clinical outcomes in mechanical circulatory support use in patients undergoing high risk on-pump cardiac surgery: Insights from the LEVO-CTS trial. Am Heart J. 2022 Jun;248:35-41. doi: 10.1016/j.ahj.2022.02.013. Epub 2022 Mar 7.
PubMed 35263653Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, Harrison RW, Hay D, Fremes S, Duncan A, Soltesz EG, Luber J, Park S, Argenziano M, Murphy E, Marcel R, Kalavrouziotis D, Nagpal D, Bozinovski J, Toller W, Heringlake M, Goodman SG, Levy JH, Harrington RA, Anstrom KJ, Alexander JH; LEVO-CTS Investigators. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032-2042. doi: 10.1056/NEJMoa1616218. Epub 2017 Mar 19.
PubMed 28316276Mehta RH, Van Diepen S, Meza J, Bokesch P, Leimberger JD, Tourt-Uhlig S, Swartz M, Parrotta J, Jankowich R, Hay D, Harrison RW, Fremes S, Goodman SG, Luber J, Toller W, Heringlake M, Anstrom KJ, Levy JH, Harrington RA, Alexander JH; LEVO-CTS Investigators. Levosimendan in patients with left ventricular systolic dysfunction undergoing cardiac surgery on cardiopulmonary bypass: Rationale and study design of the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial. Am Heart J. 2016 Dec;182:62-71. doi: 10.1016/j.ahj.2016.09.001. Epub 2016 Sep 9.
PubMed 27914501Lim JY, Deo SV, Rababa'h A, Altarabsheh SE, Cho YH, Hang D, McGraw M, Avery EG, Markowitz AH, Park SJ. Levosimendan Reduces Mortality in Adults with Left Ventricular Dysfunction Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis. J Card Surg. 2015 Jul;30(7):547-54. doi: 10.1111/jocs.12562. Epub 2015 May 19.
PubMed 25989324Toller W, Heringlake M, Guarracino F, Algotsson L, Alvarez J, Argyriadou H, Ben-Gal T, Cerny V, Cholley B, Eremenko A, Guerrero-Orriach JL, Jarvela K, Karanovic N, Kivikko M, Lahtinen P, Lomivorotov V, Mehta RH, Music S, Pollesello P, Rex S, Riha H, Rudiger A, Salmenpera M, Szudi L, Tritapepe L, Wyncoll D, Owall A. Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion. Int J Cardiol. 2015 Apr 1;184:323-336. doi: 10.1016/j.ijcard.2015.02.022. Epub 2015 Feb 24.
PubMed 25734940
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02025621
- Acronym / sponsor ID
- LEVO-CTS / TNX-LVO-01
- Keywords
- coronary artery bypass grafting, CABG, mitral valve, LCOS, low cardiac output syndrome, levosimendan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 882 participants (actual)
- Lead sponsor
- Tenax Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 22 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).
Detailed description
This study is being done to evaluate the efficacy of levosimendan compared with placebo in reducing the co-primary endpoints of 30-day composite of all-cause death or use of mechanical assist device (IABP, LVAD or ECMO) or the composite event rate of all-cause death, perioperative MI, need for dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on CPB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: Levosimendanlevosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
| Placebo | Placebo comparator | Drug: Placeboplacebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery.
- Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with mitral valve surgery, or 4) mitral valve surgery with or without other valves
- Surgery will employ CPB pump
- Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria (19 listed)
- Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.
- Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours before surgery.
- Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration).
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2.
- Weight ≥ 170 kg.
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 |
|---|---|---|
| LevosimendanAlso: Simdax | Drug | Levosimendan |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Number of Dual Efficacy Endpoint Events
Time frame: 30 days
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Number of Quad Efficacy Endpoint Events
Time frame: 30 days
Composite of all-cause death (at 30 days), or perioperative nonfatal MI [CK-MB >10xULN or >100 ng/mL, CK-MB >5xULN or 50 ng/mL with new Q wave (>0.04 seconds wide in two contiguous leads) or new left bundle branch block)] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
3 secondary outcomes
Duration of Intensive Care Unit/Critical or Coronary Care Unit (ICU/CCU) (Days)
Time frame: participants will be followed for during the participant's hospital stay up to 30 days
Incidence of Low Cardiac Output Syndrome (LCOS)
Time frame: 5 days
Postoperative Use of Secondary Inotrope
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35263653Verma S, Rathwell S, Fremes S, Zheng Y, Mehta R, Lopes RD, Alexander JH, Goodman SG, Diepen SV; LEVO-CTS investigators. Associated factors and clinical outcomes in mechanical circulatory support use in patients undergoing high risk on-pump cardiac surgery: Insights from the LEVO-CTS trial. Am Heart J. 2022 Jun;248:35-41. doi: 10.1016/j.ahj.2022.02.013. Epub 2022 Mar 7.
- Derived from this study: PubMed 28316276Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, Harrison RW, Hay D, Fremes S, Duncan A, Soltesz EG, Luber J, Park S, Argenziano M, Murphy E, Marcel R, Kalavrouziotis D, Nagpal D, Bozinovski J, Toller W, Heringlake M, Goodman SG, Levy JH, Harrington RA, Anstrom KJ, Alexander JH; LEVO-CTS Investigators. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032-2042. doi: 10.1056/NEJMoa1616218. Epub 2017 Mar 19.
- Derived from this study: PubMed 27914501Mehta RH, Van Diepen S, Meza J, Bokesch P, Leimberger JD, Tourt-Uhlig S, Swartz M, Parrotta J, Jankowich R, Hay D, Harrison RW, Fremes S, Goodman SG, Luber J, Toller W, Heringlake M, Anstrom KJ, Levy JH, Harrington RA, Alexander JH; LEVO-CTS Investigators. Levosimendan in patients with left ventricular systolic dysfunction undergoing cardiac surgery on cardiopulmonary bypass: Rationale and study design of the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial. Am Heart J. 2016 Dec;182:62-71. doi: 10.1016/j.ahj.2016.09.001. Epub 2016 Sep 9.
- Derived from this study: PubMed 25989324Lim JY, Deo SV, Rababa'h A, Altarabsheh SE, Cho YH, Hang D, McGraw M, Avery EG, Markowitz AH, Park SJ. Levosimendan Reduces Mortality in Adults with Left Ventricular Dysfunction Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis. J Card Surg. 2015 Jul;30(7):547-54. doi: 10.1111/jocs.12562. Epub 2015 May 19.
- Derived from this study: PubMed 25734940Toller W, Heringlake M, Guarracino F, Algotsson L, Alvarez J, Argyriadou H, Ben-Gal T, Cerny V, Cholley B, Eremenko A, Guerrero-Orriach JL, Jarvela K, Karanovic N, Kivikko M, Lahtinen P, Lomivorotov V, Mehta RH, Music S, Pollesello P, Rex S, Riha H, Rudiger A, Salmenpera M, Szudi L, Tritapepe L, Wyncoll D, Owall A. Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion. Int J Cardiol. 2015 Apr 1;184:323-336. doi: 10.1016/j.ijcard.2015.02.022. Epub 2015 Feb 24.
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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.
Rajendra Mehta, MD principal investigator
Duke Clinical Research Institute
John Alexander, MD study chair
Duke Clinical Research Institute
60 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levosimendan in people with Coronary Artery Bypass Grafting and Mitral Valve Surgery, run by Tenax Therapeutics, Inc. at 60 sites in 2 countries.
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 19 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 May 2018). 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?
Number of Dual Efficacy Endpoint Events (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT02025621, which also lists 5 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 21 Jun 2018.