SeverePARTNERII BNCT02184442
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
A study testing TAVR Implantation with SAPIEN XT and TAVR Implantation with SAPIEN in people with Severe and Symptomatic, run by Edwards Lifesciences at 53 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Severe, Symptomatic, Calcific Aortic Stenosis
- What is being tested?
- TAVR Implantation with SAPIEN XT and TAVR Implantation with SAPIEN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 53 sitesUnited States
- Study dates
- 9 Mar 2011to 30 May 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.
Who cannot join
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
- Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Emory University Hospital
Atlanta, Georgia, 30308
Austin Heart, PLLC
Austin, Texas, 78756
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina Charleston
Charleston, North Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22904
Northwestern Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital, Cincinnati
Cincinnati, Ohio, 45219
Morton Plant Hospital
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Heart Hospital Baylor Plano
Dallas, Texas, 75093
Medical City Dallas Hospital
Dallas, Texas, 75230
University of Colorado Hospital
Denver, Colorado, 80045
Henry Ford Hospital
Detroit, Michigan, 48202
University of Florida, Gainesville
Gainesville, Florida, 32610
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, 27834
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
Houston, Texas, 77030
Indiana University Health-Methodist Hospital
Indianapolis, Indiana, 46202
The University of Iowa
Iowa City, Iowa, 52242
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111
Scripps Green Hospital
La Jolla, California, 92037
Scripps Memorial Hospital
La Jolla, California, 92037
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Arkansas Heart Hospital/Clinic
Little Rock, Arkansas, 72211
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville - Jewish Hospital
Louisville, Kentucky, 40202
University of Wisconsin - Madison
Madison, Wisconsin, 53792
North Shore University Hospital, NY
Manhasset, New York, 11030
Baptist Memorial Hospital
Memphis, Tennessee, 38120
University of Miami
Miami, Florida, 33136
Winthrop University Hospital
Mineola, New York, 11501
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84157
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Cornell University
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
Mercy General Hospital
Sacramento, California, 95816
University of Texas Health Science Center at San Antonio (UTHSCSA)
San Antonio, Texas, 78229-3900
University of Washington
Seattle, Washington, 98195
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Washington Hospital Center (WHC)
Washington D.C., District of Columbia, 20010
York Hospital
York, Pennsylvania, 17403
About this study
Official title: The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Read the detailed description
Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).
Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Being tested
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Keywords
- SAPIEN, TAVR, THV, Aortic Stenosis, Heart Valve Disease, Aortic Valve, Retroflex, SAPIEN XT
- Medical subject headings
- Lymphoma, Follicular, Aortic Valve, Calcification of, Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR Implantation with SAPIEN XTDevice
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
TAVR Implantation with SAPIENDevice
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
| Study group | Role | What they receive |
|---|---|---|
| TAVR - SAPIEN XT | Experimental | TAVR (transaortic valve replacement) with SAPIEN XT Receives: Device: TAVR Implantation with SAPIEN XT |
| TAVR - SAPIEN | Active comparator | TAVR (transaortic valve replacement) with SAPIEN is the control arm Receives: Device: TAVR Implantation with SAPIEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
Measured: 1 Year
Secondary outcomes (3)
NYHA Classification - Change From Baseline
New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Measured: Baseline and 1 Year
Total Aortic Regurgitation - Change From Baseline
Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.
Total regurgitation at one year was analyzed in the valve implant population.
Measured: 1 Year
Effective Orifice Area - Change From Baseline
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start9 Mar 2011
- Primary completion1 May 2013
- Study completion30 May 2017
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 SevereStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American College of Cardiology
- Responsible party
- Sponsor
- Investigators
- Martin B Leon, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184442
- Sponsor's protocol ID
- 2010-12-PIIB
- Acronym
- PARTNERII B
- Status last verified
- Aug 2018
- First submitted
- 17 Jan 2014
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
PubMed 35656983Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
PubMed 35595203Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
PubMed 31883339Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
PubMed 31690104Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
PubMed 31525069
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
- ClinicalTrials.gov ID
- NCT02184442
- Acronym / sponsor ID
- PARTNERII B / 2010-12-PIIB
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Keywords
- SAPIEN, TAVR, THV, Aortic Stenosis, Heart Valve Disease, Aortic Valve, Retroflex, SAPIEN XT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- American College of Cardiology
- Study start
- 9 Mar 2011 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Posted 14 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Detailed description
Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).
Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR - SAPIEN XT | Experimental | Device: TAVR Implantation with SAPIEN XTTAVR (transaortic valve replacement) with SAPIEN XT |
| TAVR - SAPIEN | Active comparator | Device: TAVR Implantation with SAPIENTAVR (transaortic valve replacement) with SAPIEN is the control arm |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.
Key exclusion criteria (5 listed)
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
- Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
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 |
|---|---|---|
| TAVR Implantation with SAPIEN XTInoperable operable patients requiring the transcatheter aortic heart valve replacement | Device | TAVR - SAPIEN XT |
| TAVR Implantation with SAPIENInoperable operable patients requiring the transcatheter aortic heart valve replacement | Device | TAVR - SAPIEN |
Primary outcome
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
Time frame: 1 Year
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
3 secondary outcomes
NYHA Classification - Change From Baseline
Time frame: Baseline and 1 Year
Total Aortic Regurgitation - Change From Baseline
Time frame: 1 Year
Effective Orifice Area - Change From Baseline
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35656983Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
- Derived from this study: PubMed 35595203Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
- Derived from this study: PubMed 31883339Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
- Derived from this study: PubMed 31690104Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
- Derived from this study: PubMed 31525069Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
- Individual participant dataSharing planned: No
Related trials for Severe
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
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.
Martin B Leon, MD principal investigator
Columbia University
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR Implantation with SAPIEN XT and TAVR Implantation with SAPIEN in people with Severe and Symptomatic, run by Edwards Lifesciences at 53 sites 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 5 inclusion and 5 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 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 Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization (time frame: 1 Year). 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 NCT02184442, 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 25 Sep 2018.