A Phase 3 interventional study of Edoxaban and Standard of Care (SOC) in Cardiac Disease, sponsored by Daiichi Sankyo. Completed at 48 sites in 14 countries. Open to participants aged 1 Day to 17 Years. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Prevention
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.
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.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's enrollment of 168 is above the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two out of three participants will be randomized for treatment with edoxaban solution or tablets
Drug: Edoxaban
One out of three participants will be randomized for treatment with the institution's SOC regimen
Drug: Standard of Care (SOC)
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
Also known as: Lixiana, Savaysa
Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen
Also known as: Warfarin/heparin, Enoxaparin
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.
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 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).
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
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).
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
Death due to any cause (all-cause mortality) was assessed.
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
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.
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
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).
Time frame: 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).
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
Death due to any cause (all-cause mortality) was assessed.
Time frame: Month 4 up to Month 13
A total of 168 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment; 167 participants received treatment and were included in the modified Intent to Treat and Safety Populations.
| Milestone | Main Treatment Period: Edoxaban | Main Treatment Period: Standard of Care (SOC) | Extension Period: Edoxaban Only |
|---|---|---|---|
| Started | 110 | 58 | 0 |
| Modified intent to treat population | 109 | 58 | 0 |
| Completed | 107 | 55 | 0 |
| Not completed | 3 | 3 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Participant discontinued at principal investigator discretion | 0 | 1 | 0 |
| Milestone | Main Treatment Period: Edoxaban | Main Treatment Period: Standard of Care (SOC) | Extension Period: Edoxaban Only |
|---|---|---|---|
| Started | 0 | 0 | 147 |
| Completed | 0 | 0 | 144 |
| Not completed | 0 | 0 | 3 |
| Withdrew: Adverse event | 0 | 0 | 2 |
| Withdrew: Subject discontinued at pi discretion | 0 | 0 | 1 |
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.
| Participants | Edoxaban | Standard of Care (SOC) |
|---|---|---|
| Major or CRNM bleeding events | 1 | 1 |
| Major bleeding events | 0 | 0 |
| All bleeding events (Major, CRNM, minor) | 4 | 2 |
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).
| Participants | Edoxaban | Standard of Care (SOC) |
|---|---|---|
| Thromboembolic event, Any Event | 0 | 1 |
| Deep vein thrombosis | 0 | 1 |
| Pulmonary embolism | 0 | 1 |
| Stroke | 0 | 0 |
| Systemic embolic event | 0 | 0 |
| Intracardiac thrombus | 0 | 0 |
| Myocardial infarction | 0 | 0 |
| Asymptomatic intracardiac thrombus identified by cardiac imaging | 0 | 0 |
| Death as a result of TE | 0 | 0 |
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).
| Participants | Edoxaban | Standard of Care (SOC) |
|---|---|---|
| Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period | 0 | 0 |
Death due to any cause (all-cause mortality) was assessed.
| Participants | Edoxaban | Standard of Care (SOC) |
|---|---|---|
| Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period | 0 | 0 |
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.
| Participants | Edoxaban |
|---|---|
| Major or CRNM bleeding events | 1 |
| Major bleeding events | 1 |
| All bleeding events (Major, CRNM, minor) | 4 |
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).
| Participants | Edoxaban |
|---|---|
| Thromboembolic event, Any Event | 4 |
| Deep vein thrombosis | 0 |
| Pulmonary embolism | 0 |
| Stroke | 2 |
| Systemic embolic event | 0 |
| Intracardiac thrombus | 0 |
| Myocardial infarction | 2 |
| Asymptomatic intracardiac thrombus identified by cardiac imaging | 0 |
| Death as a result of TE | 0 |
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).
| Participants | Edoxaban |
|---|---|
| Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period | 0 |
Death due to any cause (all-cause mortality) was assessed.
| Participants | Edoxaban |
|---|---|
| Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period | 2 |
Collected over Adverse events (AEs) were collected from the time of signing the informed consent form up to 30 days after the last dose of study drug, up to 13 months.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main Treatment Period: Edoxaban | 0/109 (0%) | 5/109 (4.6%) | 51/109 (46.8%) |
| Main Treatment Period: Standard of Care (SOC) | 0/58 (0%) | 3/58 (5.2%) | 24/58 (41.4%) |
| Extension Period: Edoxaban Only | 2/144 (1.4%) | 19/144 (13.2%) | 69/144 (47.9%) |
| Event | Main Treatment Period: Edoxaban | Main Treatment Period: Standard of Care (SOC) | Extension Period: Edoxaban Only |
|---|---|---|---|
| Cardiac failureCardiac disorders | 2/109 | 1/58 | 0/144 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/109 | 0/58 | 0/144 |
| VomitingGastrointestinal disorders | 0/109 | 1/58 | 1/144 |
| HyponatraemiaMetabolism and nutrition disorders | 0/109 | 1/58 | 0/144 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/109 | 1/58 | 0/144 |
| PyrexiaGeneral disorders | 0/109 | 0/58 | 2/144 |
| Coronary artery thrombosisCardiac disorders | 1/109 | 0/58 | 0/144 |
| HaemolysisBlood and lymphatic system disorders | 0/109 | 0/58 | 1/144 |
| Immune thrombocytopeniaBlood and lymphatic system disorders | 0/109 | 0/58 | 1/144 |
| Atrial thrombosisCardiac disorders | 0/109 | 0/58 | 1/144 |
| Event | Main Treatment Period: Edoxaban | Main Treatment Period: Standard of Care (SOC) | Extension Period: Edoxaban Only |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 14/109 | 2/58 | 9/144 |
| PyrexiaGeneral disorders | 5/109 | 1/58 | 13/144 |
| HeadacheNervous system disorders | 5/109 | 2/58 | 9/144 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/109 | 2/58 | 9/144 |
| NasopharyngitisInfections and infestations | 4/109 | 3/58 | 4/144 |
| Upper respiratory tract infectionInfections and infestations | 2/109 | 2/58 | 7/144 |
| VomitingGastrointestinal disorders | 3/109 | 2/58 | 6/144 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 3/109 | 2/58 | 6/144 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 4/109 | 1/58 | 3/144 |
| InfluenzaInfections and infestations | 1/109 | 0/58 | 5/144 |
Demographic and baseline characteristics were assessed in the Intent to Treat Population (ITT).
| Age, Continuous(years) | Edoxaban | Standard of Care (SOC) | Total |
|---|---|---|---|
| Mean | 7.7 ± 4.8 | 7.3 ± 5.1 | 7.6 ± 4.9 |
| Age, Customized(Participants) | Edoxaban | Standard of Care (SOC) | Total |
|---|---|---|---|
| 0 to 6 months | 1 | 3 | 4 |
| 6 months to <2 years | 7 | 5 | 12 |
| 2 to <6 years | 33 | 17 | 50 |
| 6 to <12 years | 41 | 17 | 58 |
| 12 to <18 years | 28 | 16 | 44 |
| Sex: Female, Male(Participants) | Edoxaban | Standard of Care (SOC) | Total |
|---|---|---|---|
| Female | 38 | 21 | 59 |
| Male | 72 | 37 | 109 |
| Race/Ethnicity, Customized(Participants) | Edoxaban | Standard of Care (SOC) | Total |
|---|---|---|---|
| Asian | 6 | 3 | 9 |
| Black or African American | 4 | 3 | 7 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Native Hawaiian/Pacific Islander | 2 | 1 | 3 |
| White | 80 | 39 | 119 |
| Other | 10 | 7 | 17 |
| Unknown | 8 | 5 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
Ran from May 2018 to primary completion in Dec 2021, 42 months.
Results were first posted in Jul 2022, 7 months after primary completion.
Of 32 phase 3 interventional studies under Heart Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Edoxaban