Venous ThromboembolismPhase 3NCT02197416
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
A Phase 3 study testing dabigatran etexilate in people with Venous Thromboembolism and Secondary Prevention, run by Boehringer Ingelheim at 62 sites in 22 countries.
Trial summary
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Venous Thromboembolism, Secondary Prevention
- What is being tested?
- dabigatran etexilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 62 sitesin 22 countries
- Study dates
- 29 Sep 2014to 19 Nov 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
- Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2 and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial. Patients, who during the treatment phase of 1160.106 trial were switched from dabigatran etexilate to SOC arm for any reason, are not eligible for this study.
- Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.)
- Written informed consent form (ICF) provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations.
- Further inclusion criteria apply
Who cannot join
- Conditions associated with an increased risk of bleeding
- Renal dysfunction (eGFR < 50 mL/min/1.73m^2 using the Schwartz formula) or requirement for dialysis. eGFR retesting during the screening period is allowed (once).
- Active infective endocarditis
- Subjects with a heart valve prosthesis requiring anticoagulation.
- Hepatic disease: Active liver disease, including known active hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening
- Pregnant or breast feeding females. Females who have reached menarche and are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and / or do not agree to adhere to pregnancy testing required by this protocol
Show all 13Show fewer
- Patients in age group 0 to < 2 years with gestational age at birth < 37 weeks or with body weight lower than the 3rd percentile
- Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2
- Patients who have taken restricted medication prior to first dose of study medication
- Patients who have received an investigational drug in the past 30 days prior to screening, except patients who have completed the treatment period (up to Visit 8) in 1160.106 trial
- Patients who are allergic/sensitive to any component of the study medication including solvent
- Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment
- Further exclusion criteria apply
Trial locations and contacts
62 sites in 22 countries.
62 sites in 22 countries
United States9 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1083
Alliance for Childhood Diseases
Las Vegas, Nevada, 89135
University of Miami
Miami, Florida, 33136
University of California Davis
Sacramento, California, 95817
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
St. Joseph's Children's Hospital
Tampa, Florida, 33607
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Russia8 sites
Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan
Kazan', 420138
Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo
Kemerovo, 650002
Morozovskaya Children Clin.Hosp.,Haematological Dept, Moscow
Moscow, 119049
Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol
Moscow, 125373
St.Petersburg State Pediatric Univ.Ministry of Healthcare RF
Saint Petersburg, 194100
Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery
Tyument, 625023
State Budget Healthcare Institution "Republican children's clinical hospital"
Ufa, 450106
Childr.CityClin.Hos#9,pediatric&Neonatal Neurol.Ekaterinburg
Yekaterinburg, 620134
Turkey (Türkiye)7 sites
Cukurova Universitesi Tip Fakultesi Cocuk Sagligi
Adana, 1330
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100
Akdeniz Universitesi Tip Fakultesi
Antalya, 7058
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH
Istanbul, 34303
Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali
Izmir, 35040
Necmettin Erbakan Universitesi Meram Tip Fakultesi
Konya, 42080
Czechia5 sites
University Hospital Brno
Brno, 61300
University Hospital Olomouc
Olomouc, 77900
University Hospital Ostrava
Ostrava, 70852
University Hospital Plzen, Plzen-Lochotin
Plzen - Lochotin, 304 60
University Hospital Motol
Prague, 15006
Canada4 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
CHU Sainte-Justine
Montreal, Ontario, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Italy4 sites
A.O. Univ. Policlinico "Paolo Giaccone"
Palermo, 90127
Università degli Studi "La Sapienza"
Roma, 00161
Osp. Pediatrico Bambin Gesù
Roma, 00165
Ospedale Infantile Regina Margherita
Torino, 10126
Belgium3 sites
Brussels - UNIV UZ Brussel
Brussels, 1090
UNIV UZ Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
Brazil3 sites
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas, 13059-740
Faculdade de Ciencias Medicas da UNICAMP
Campinas, 13083970
Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP
São Paulo, 04039-001
Germany3 sites
Universitätsklinikum Essen AöR
Essen, 45147
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
Universitätsklinikum Münster
Münster, 48149
Ukraine3 sites
Reg.Children Hosp.Dnipropetrovsk
Dnipropetrovsk, 49100
Western Ukrainian Spec.Children Med.Center,Lviv
Lviv, 79035
Reg.Children Hosp,Vinnytsia
Vinnytsia, 21029
Norway2 sites
Haukeland Universitetssykehus
Bergen, N-5021
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, N-0372
Denmark1 site
Rigshospitalet, København, Børneonkologisk Afsnit 5002
Copenhagen, 2100
Lithuania1 site
Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius
Vilnius, 08406
About this study
Official title: Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.
- Conditions
- Venous Thromboembolism, Secondary Prevention
- Being tested
- dabigatran etexilate
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabigatran etexilateDrug
Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation
| Study group | Role | What they receive |
|---|---|---|
| dabigatran etexilate | Experimental | Not described Receives: Drug: dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months
The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Measured: At month 6 (Week 26) and 12 (Week 52) of on treatment period
Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months
The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Measured: At month 6 (Week 26) and month 12 (Week 52) of on treatment period
Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months
The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Measured: At month 6 (Week 26) and 12 (Week 52) of on treatment period
Secondary outcomes (8)
Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months
The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Measured: At month 6 (Week 26) and 12 (Week 52) of on treatment period
Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period
Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Measured: From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
Measured: At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
Measured: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
Measured: At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
Measured: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
Measured: At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
Measured: dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start29 Sep 2014
- Primary completion16 Oct 2019
- Study completion19 Nov 2019
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 (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197416
- Sponsor's protocol ID
- 1160.108
- Other IDs
- 2014-000583-18, 2014
- Status last verified
- May 2020
- First submitted
- 21 Jul 2014
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Albisetti M, Tartakovsky I, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Luciani M, Nurmeev I, Gorbatikov K, Miede C, Brueckmann M, Brandao LR; Study Investigators. Dabigatran for Treatment and Secondary Prevention of Venous Thromboembolism in Pediatric Congenital Heart Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e028957. doi: 10.1161/JAHA.122.028957. Epub 2024 Feb 13.
PubMed 38348778Brandao LR, Tartakovsky I, Albisetti M, Halton J, Bomgaars L, Chalmers E, Luciani M, Saracco P, Felgenhauer J, Lvova O, Simetzberger M, Sun Z, Mitchell LG. Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Adv. 2022 Nov 22;6(22):5908-5923. doi: 10.1182/bloodadvances.2021005681.
PubMed 36150047Brandao LR, Albisetti M, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Svirin P, Kuhn T, Zapletal O, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Brueckmann M, Luciani M; DIVERSITY Study Investigators. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood. 2020 Feb 13;135(7):491-504. doi: 10.1182/blood.2019000998.
PubMed 31805182
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years
- ClinicalTrials.gov ID
- NCT02197416
- Acronym / sponsor ID
- 1160.108
- Conditions
- Venous Thromboembolism, Secondary Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2014 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dabigatran etexilate | Experimental | Drug: dabigatran etexilate |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
- Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2 and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial. Patients, who during the treatment phase of 1160.106 trial were switched from dabigatran etexilate to SOC arm for any reason, are not eligible for this study.
- Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.)
- Written informed consent form (ICF) provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations.
- Further inclusion criteria apply
Key exclusion criteria (13 listed)
- Conditions associated with an increased risk of bleeding
- Renal dysfunction (eGFR < 50 mL/min/1.73m^2 using the Schwartz formula) or requirement for dialysis. eGFR retesting during the screening period is allowed (once).
- Active infective endocarditis
- Subjects with a heart valve prosthesis requiring anticoagulation.
- Hepatic disease: Active liver disease, including known active hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening
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 |
|---|---|---|
| dabigatran etexilateAge and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation | Drug | dabigatran etexilate |
Primary outcome
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months
Time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period
The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months
Time frame: At month 6 (Week 26) and month 12 (Week 52) of on treatment period
The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months
Time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period
The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
8 secondary outcomes
Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months
Time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period
Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period
Time frame: From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
Time frame: At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
Time frame: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
Time frame: At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
Time frame: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
Time frame: At Visit 3 (day 4 after first dose of trial medication)
Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
Time frame: dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38348778Albisetti M, Tartakovsky I, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Luciani M, Nurmeev I, Gorbatikov K, Miede C, Brueckmann M, Brandao LR; Study Investigators. Dabigatran for Treatment and Secondary Prevention of Venous Thromboembolism in Pediatric Congenital Heart Disease. J Am Heart Assoc. 2024 Feb 20;13(4):e028957. doi: 10.1161/JAHA.122.028957. Epub 2024 Feb 13.
- Derived from this study: PubMed 36150047Brandao LR, Tartakovsky I, Albisetti M, Halton J, Bomgaars L, Chalmers E, Luciani M, Saracco P, Felgenhauer J, Lvova O, Simetzberger M, Sun Z, Mitchell LG. Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Adv. 2022 Nov 22;6(22):5908-5923. doi: 10.1182/bloodadvances.2021005681.
- Derived from this study: PubMed 31805182Brandao LR, Albisetti M, Halton J, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Svirin P, Kuhn T, Zapletal O, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Brueckmann M, Luciani M; DIVERSITY Study Investigators. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood. 2020 Feb 13;135(7):491-504. doi: 10.1182/blood.2019000998.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
62 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dabigatran etexilate in people with Venous Thromboembolism and Secondary Prevention, run by Boehringer Ingelheim at 62 sites in 22 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 5 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Russia, Turkey (Türkiye), Czechia, Canada and 17 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 4 Jun 2020). 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?
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months (time frame: At month 6 (Week 26) and 12 (Week 52) of on treatment period). The study lists 3 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 NCT02197416, which also lists 3 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 4 Jun 2020.