Cardiac DiseasePhase 3NCT03395639
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A Phase 3 study testing Edoxaban in people with Cardiac Disease, run by Daiichi Sankyo at 48 sites in 14 countries.
Trial summary
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Edoxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 48 sitesin 14 countries
- Study dates
- 15 May 2018to 3 Dec 2021
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis
- Either one of the following:
- a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).
- OR
- a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.
- Cardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.
Show all 9Show fewer
- Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)
- Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.
- If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study
Who cannot join
- Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period
- Has mechanical heart valve(s)
- Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant
- Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related
- Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded
- Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk
Show all 13Show fewer
- Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size
- Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg
- Has thrombocytopenia or life expectancy less than three months
- Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy
- Is pregnant or breastfeeding
- Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)
- Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol
Trial locations and contacts
48 sites in 14 countries.
48 sites in 14 countries
United States14 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Novant Health Heart and Vascular institute
Charlotte, North Carolina, 28204
University of Virginia Health System
Charlottesville, Virginia, 22903
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Florida College of Medicine
Gainesville, Florida, 32610
East Carolina Heart Institute @ ECU
Greenville, North Carolina, 27834
Cedars Sinai Medical Center (ECG)
Los Angeles, California, 90048
Cardon Childrens Medical Center
Mesa, Arizona, 85202
Ochsner Medical Center
New Orleans, Louisiana, 70121
OU Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of California-San Francisco Department of Pediatrics - Hematology/Oncology
San Francisco, California, 94158
Seattle Children's Research Institute
Seattle, Washington, 98105
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Egypt5 sites
Alexandria Clinical Research Center, Faculty of Medicine
Alexandria, 21131
Kasr Elainy School of Medicine, Abo Elreesh Hospital (Japanese Hospital), Ali Basha Ibrahim ST Faculty of Medicine Cairo University
Cairo, 11562
Ain Shams University Hospital
Cairo, 11566
Suez Canal University Hospital
Ismailia, 41522
Zagazig University Hospital
Zagazig, Al Sharkeya, 44519
Turkey (Türkiye)5 sites
Hacettepe University Medical Faculty
Ankara, 06100
Erciyes University Medical Faculty, Department of Children Hospital
Edirne, Kayseri, 38039
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
Ege University Faculty of Medicine Department of Child Health and Diseases
Izmir, 35040
Izmir-Dr. Behçet Uz. Pediatric Diseases and Surgery Training and Research Hospital- Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35210
Canada3 sites
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
McGill University Health Centre/Glen Site/Montreal Children's Hospital
Pierrefonds, Quebec, H9H 4Y6
France3 sites
Pediatric and Congenital Cardiology and Pulmonology Department; Arnaud De Villeneuve University Hospital
Montpellier, Herault, 34295
Pediatric Cardiology Department, Hospital Necker Enfants Malades, APHP, Université Paris Descartes
Paris, Paris Cedex 15, 75015
Hôpital Des Enfants, Bâtiment Modulaire
Toulouse, Haute Garonne, 31059
Israel3 sites
Soroka University Medical Center
Beersheba, 8410101
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
Sheba Medical Center
Ramat Gan, 5265601
Ukraine3 sites
Communal Institution Dnipropetrovsk Regional Pediatric Clinical Hospital of Dnipropetrovsk Regional Council, State Institution Dnipropetrovsk Medical Academy of MoH of Ukraine
Dnipro, 49100
Communal Healthcare Institution Regional Pediatric Clinical Hospital, Kharkiv National Medical University
Kharkiv, 61093
Vynnitsa Regional Children Clinical Hospital Policlinic Dept
Vinnytsia, 21000
United Kingdom3 sites
Ward 2B, Royal Hospital for Children
Glasgow, Strathclyde, G51 4TF
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
Royal Brompton Hospital
London, Greater London, SW3 6HP
Hungary2 sites
Gottsegen Gyorgy Orszagos Kardiologiai Intezet
Budapest, 1096
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720
India2 sites
Institute of Child Health
Kolkata, 700017
Nirmal Hospital Private Limited
Surat, Gujarat, 395002
Lebanon2 sites
Children's Heart Centre at the American University of Beirut Medical Center
Beirut, 11-0236
Hotel Dieu de France Hospital
Beirut, 166830
About this study
Official title: An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).
All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.
The study will find out if edoxaban is safer and more effective than the standard of care.
Read the detailed description
The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.
The key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.
- Conditions
- Cardiac Disease
- Being tested
- Edoxaban, Standard of Care (SOC)
- Keywords
- Children, Pediatrics, Cardiac disease with potential for thromboembolic complications, Prophylactic treatment, Anticoagulant drugs
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana, Savaysa
Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration
Standard of Care (SOC)Drug
Also called Warfarin/heparin, Enoxaparin
Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban | Experimental | Two out of three participants will be randomized for treatment with edoxaban solution or tablets Receives: Drug: Edoxaban |
| Standard of Care (SOC) | Active comparator | One out of three participants will be randomized for treatment with the institution's SOC regimen Receives: Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of >2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding.
Measured: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Secondary outcomes (7)
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Measured: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Measured: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period
Death due to any cause (all-cause mortality) was assessed.
Measured: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Number of Participants With Adjudicated Bleeding Events During the Extension Period
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of >2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding.
Measured: Month 4 up to Month 13
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Measured: Month 4 up to Month 13
Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Measured: Month 4 up to Month 13
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period
Death due to any cause (all-cause mortality) was assessed.
Measured: Month 4 up to Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start15 May 2018
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
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 Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395639
- Sponsor's protocol ID
- DU176b-C-U313
- Other IDs
- 2017-000475-90, 2017
- Status last verified
- Jul 2022
- First submitted
- 4 Jan 2018
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Portman MA, Jacobs JP, Newburger JW, Berger F, Grosso MA, Duggal A, Tao B, Goldenberg NA; ENNOBLE-ATE Trial Investigators. Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease. J Am Coll Cardiol. 2022 Dec 13;80(24):2301-2310. doi: 10.1016/j.jacc.2022.09.031. Epub 2022 Oct 31.
PubMed 36328157
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events
- ClinicalTrials.gov ID
- NCT03395639
- Acronym / sponsor ID
- DU176b-C-U313
- Conditions
- Cardiac Disease
- Keywords
- Children, Pediatrics, Cardiac disease with potential for thromboembolic complications, Prophylactic treatment, Anticoagulant drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 15 May 2018 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Posted 26 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).
All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.
The study will find out if edoxaban is safer and more effective than the standard of care.
Detailed description
The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.
The key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | Experimental | Drug: EdoxabanTwo out of three participants will be randomized for treatment with edoxaban solution or tablets |
| Standard of Care (SOC) | Active comparator | Drug: Standard of Care (SOC)One out of three participants will be randomized for treatment with the institution's SOC regimen |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis
- a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).
- OR
- a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.
- Cardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.
Key exclusion criteria (13 listed)
- Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period
- Has mechanical heart valve(s)
- Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant
- Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related
- Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded
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 |
|---|---|---|
| EdoxabanAlso: Lixiana, SavaysaEdoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration | Drug | Edoxaban |
| Standard of Care (SOC)Also: Warfarin/heparin, EnoxaparinStandard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen | Drug | Standard of Care (SOC) |
Primary outcome
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of >2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding.
7 secondary outcomes
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Number of Participants With Adjudicated Bleeding Events During the Extension Period
Time frame: Month 4 up to Month 13
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Time frame: Month 4 up to Month 13
Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period
Time frame: Month 4 up to Month 13
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period
Time frame: Month 4 up to Month 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36328157Portman MA, Jacobs JP, Newburger JW, Berger F, Grosso MA, Duggal A, Tao B, Goldenberg NA; ENNOBLE-ATE Trial Investigators. Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease. J Am Coll Cardiol. 2022 Dec 13;80(24):2301-2310. doi: 10.1016/j.jacc.2022.09.031. Epub 2022 Oct 31.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
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
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Clinical Study Leader study director
Daiichi Sankyo
48 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Edoxaban in people with Cardiac Disease, run by Daiichi Sankyo at 48 sites in 14 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 9 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Egypt, Turkey (Türkiye), Canada, France and 9 more countries. 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 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 26 Jul 2022). 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 Adjudicated Bleeding Events Within the Main Treatment Period (time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier). 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 NCT03395639, 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 26 Jul 2022.