Cardio-vascular DiseasesNCT01587053
Anti Vitamin K Therapeutic Education
An observational study of Cardio-vascular Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Cardio-vascular Diseases
- What is being tested?
- therapeutic education program
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children from 0 to 18 years having AVK prescription
Who may be able to join
- age from 0 to 18 years
- AVK prescription
- to accept participating to AVK therapeutic education program
- informed consent form of parents or legal person
Who cannot join
- parents or legal person refusal to enter in the AVK therapeutic education
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
Official title: Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years
The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.
- Conditions
- Cardio-vascular Diseases
- Being tested
- therapeutic education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic education programOther
| Study group | Role | What they receive |
|---|---|---|
| AVK | patient with AVK treatment Receives: Other: therapeutic education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range)
Measured: up to 1 year
Secondary outcomes (1)
Quality of life questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardio-vascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Principal investigator, Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587053
- Sponsor's protocol ID
- 8745
- Status last verified
- Nov 2020
- First submitted
- 12 Apr 2012
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020 Dec;113(12):811-820. doi: 10.1016/j.acvd.2020.05.022. Epub 2020 Oct 14.
PubMed 33069639
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years
- ClinicalTrials.gov ID
- NCT01587053
- Acronym / sponsor ID
- 8745
- Conditions
- Cardio-vascular Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
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 measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVK | – | Other: therapeutic education programpatient with AVK treatment |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children from 0 to 18 years having AVK prescription
Key inclusion criteria (4 listed)
- age from 0 to 18 years
- AVK prescription
- to accept participating to AVK therapeutic education program
- informed consent form of parents or legal person
Key exclusion criteria (1 listed)
- parents or legal person refusal to enter in the AVK therapeutic education
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 |
|---|---|---|
| therapeutic education program | Other | AVK |
Primary outcome
INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range)
Time frame: up to 1 year
1 secondary outcome
Quality of life questionnaire
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Results publication: PubMed 33069639Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020 Dec;113(12):811-820. doi: 10.1016/j.acvd.2020.05.022. Epub 2020 Oct 14.
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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.
Pascal AMEDRO, MD, PhD principal investigator
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-vascular Diseases, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
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?
INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) (time frame: up to 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 NCT01587053, 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 2 Dec 2020.