Atrial FibrillationADAGENCT02464488
New Oral Direct Anticoagulants in Patients 80 Years Old and Over : a Population Pharmacokinetics Study
An observational study of Atrial Fibrillation, run by Hôpital Charles Foix at 2 sites in France.
Trial summary
Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Plasma drug concentrations
- How many people
- 232 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2015to 25 Aug 2021
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation
Who may be able to join
- Age 80 years or older
- Under treatment with dabigatran, rivaroxaban or apixaban
- For non-valvular atrial fibrillation
Who cannot join
- Mechanical (non-biological) heart valve
- Any severe condition leading to a short estimated life expectance (a few months)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Charles Foix
Ivry-sur-Seine, Île-de-France Region, 94205
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, 75015
About this study
Official title: Study of Interindividual Variability in the Response to New Oral Direct Anticoagulants (Dabigatran Etexilate, Rivaroxaban or Apixaban) in Patients 80 Years Old and Over, Using a Population Pharmacokinetics Approach.
Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.
Read the detailed description
Several new oral direct anticoagulants have been recently marketed. A main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study. This is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. Each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. In addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Plasma drug concentrations
- Keywords
- Anticoagulants, Factor Xa Inhibitors, Antithrombins, Pharmacokinetics, Aged, 80 years and older
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma drug concentrationsOther
Measure of plasma concentrations of the anticoagulant drug taken by the patient
| Study group | Role | What they receive |
|---|---|---|
| Main cohort (only cohort of the study) | Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation. All patients will have plasma drug concentrations measured and will be followed afterwards similarly Receives: Other: Plasma drug concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacologic parameters of new oral anticoagulants in elderly patients
Estimated area under the curve (AUC) of each of the 3 drugs studied
Measured: 1 to 3 weeks
Secondary outcomes (2)
Thromboembolic events
Any thromboembolic event (composite of ischemic stroke, systemic embolism or acute coronary syndrome) in the year after inclusion
Measured: 1 year
Hemorrhagic events
Major hemorrhagic events in the year after inclusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start1 Jan 2015
- Primary completion30 May 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Charles Foix
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes, Sorbonne University, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Carmelo Lafuente, MD, PhD, Principal investigator, Hôpital Charles Foix, APHP, Université Paris 6 UPMCJulien Le Guen, MD, Principal investigator, Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464488
- Sponsor's protocol ID
- cfx-adage-2015
- Acronym
- ADAGE
- Status last verified
- Aug 2021
- First submitted
- 2 Jun 2015
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Interindividual Variability in the Response to New Oral Direct Anticoagulants (Dabigatran Etexilate, Rivaroxaban or Apixaban) in Patients 80 Years Old and Over, Using a Population Pharmacokinetics Approach.
- ClinicalTrials.gov ID
- NCT02464488
- Acronym / sponsor ID
- ADAGE / cfx-adage-2015
- Conditions
- Atrial Fibrillation
- Keywords
- Anticoagulants, Factor Xa Inhibitors, Antithrombins, Pharmacokinetics, Aged, 80 years and older
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Hôpital Charles FoixUniversity, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes, Sorbonne University, Assistance Publique - Hôpitaux de Paris
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 8 Jun 2015 (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.
Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.
Detailed description
Several new oral direct anticoagulants have been recently marketed. A main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study. This is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. Each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. In addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main cohort (only cohort of the study) | – | Other: Plasma drug concentrationsPatients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation. All patients will have plasma drug concentrations measured and will be followed afterwards similarly |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 80 years or older under treatment with dabigatran, rivaroxaban or apixaban because atrial fibrillation
Key inclusion criteria (3 listed)
- Age 80 years or older
- Under treatment with dabigatran, rivaroxaban or apixaban
- For non-valvular atrial fibrillation
Key exclusion criteria (2 listed)
- Mechanical (non-biological) heart valve
- Any severe condition leading to a short estimated life expectance (a few months)
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 |
|---|---|---|
| Plasma drug concentrationsMeasure of plasma concentrations of the anticoagulant drug taken by the patient | Other | Main cohort (only cohort of the study) |
Primary outcome
Pharmacologic parameters of new oral anticoagulants in elderly patients
Time frame: 1 to 3 weeks
Estimated area under the curve (AUC) of each of the 3 drugs studied
2 secondary outcomes
Thromboembolic events
Time frame: 1 year
Hemorrhagic events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Carmelo Lafuente, MD, PhD principal investigator
Hôpital Charles Foix, APHP, Université Paris 6 UPMC
Julien Le Guen, MD principal investigator
Hôpital Européen Georges Pompidou, APHP, Université Paris 5 Descartes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Hôpital Charles Foix at 2 sites 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 3 inclusion and 2 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacologic parameters of new oral anticoagulants in elderly patients (time frame: 1 to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2021.