AnticoagulantANTIGOAGNCT03172546
Determinants of Oral Anticoagulants' Activity
An observational study of Anticoagulant, run by University Hospital, Lille at 1 site in France.
Trial summary
The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant
- What is being tested?
- PK-PD genetic polymorphisms
- Type of treatment
- Pill or oral medicine
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2017to 15 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed by all patient receiving a direct oral anticoagulant inside the University Hospital whatever the clinical indication
Who may be able to join
- Patient receiving direct oral anticoagulant
- Complete blood count and measure of hemostasis planned
- Patient able to give consent
- Patient with health insurance
Who cannot join
- Patient not able to consent
- Patient under 18 years old
- Patient refusal
- Patient without health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants.
The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up.
Results will lead to a better prediction of both drug response and risk of complications.
Read the detailed description
Direct oral anticoagulants are changing clinical practices but a better knowledge of factors that may predict both drug response and risk of complications is need.
Anticoagulant activity is influenced by different factors. Because the biological activity is not easy to measure everywhere, it is important to clearly determine factors that are involved.
A cohort of 550 patients that receive either an anti-IIa or an anti-Xa will be recruited.
The primary objective is to determine clinical, biological and genetic determinants of anticoagulant activity.
This objective will be assessed through a multivariate logistic regression (separately for anti-IIa and anti-Xa) with anticoagulant activity as dependent variable.
Variables that will be included in the statistical model are those known or measured at the entry in the cohort such as :
- Clinical factors : age, sex, weight, dosage and time of the last dose
- Biological factors : serum creatinine level, plasma concentration of the drug
- Genetic polymorphisms :
Factor II and CES1 for anti-IIa drugs Factor X, CYP3, CYP3A4, CYP3A5 and ABCG2 for anti-Xa drugs.
By using the same statistical approach and the same variables, predictive factors of either hemorrhagic or thrombotic events will also be evaluated on the whole cohort. The occurence of hemorrhagic and thrombotic complications will then be assessed through a phone call every 3 months during a one-year follow-up.
- Conditions
- Anticoagulant
- Being tested
- PK-PD genetic polymorphisms
- Keywords
- direct oral anticoagulant, hemorrhagic complication, thrombotic complication, genetic polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK-PD genetic polymorphismsGenetic
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
| Study group | Role | What they receive |
|---|---|---|
| Anti-IIa users | Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti IIa anticoagulant including analysis of PK-PD genetic polymorphisms Receives: Genetic: PK-PD genetic polymorphisms | |
| Anti-Xa users | Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti Xa anticoagulant including analysis of PK-PD genetic polymorphisms Receives: Genetic: PK-PD genetic polymorphisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of anticoagulant activity level
Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity
Measured: Baseline
Secondary outcomes (2)
Occurence of any hemorrhagic complication
Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant
Measured: One year follow-up
Occurence of any thrombotic complication
Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start6 Jul 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Why it stopped: not sufficiency inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Deplanque, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172546
- Sponsor's protocol ID
- 2014_26
- Other IDs
- 2015-A01596-43
- Acronym
- ANTIGOAG
- Status last verified
- Oct 2019
- First submitted
- 24 May 2017
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
- ClinicalTrials.gov ID
- NCT03172546
- Acronym / sponsor ID
- ANTIGOAG / 2014_26
- Conditions
- Anticoagulant
- Keywords
- direct oral anticoagulant, hemorrhagic complication, thrombotic complication, genetic polymorphisms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not sufficiency inclusion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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 primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants.
The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up.
Results will lead to a better prediction of both drug response and risk of complications.
Detailed description
Direct oral anticoagulants are changing clinical practices but a better knowledge of factors that may predict both drug response and risk of complications is need.
Anticoagulant activity is influenced by different factors. Because the biological activity is not easy to measure everywhere, it is important to clearly determine factors that are involved.
A cohort of 550 patients that receive either an anti-IIa or an anti-Xa will be recruited.
The primary objective is to determine clinical, biological and genetic determinants of anticoagulant activity.
This objective will be assessed through a multivariate logistic regression (separately for anti-IIa and anti-Xa) with anticoagulant activity as dependent variable.
Variables that will be included in the statistical model are those known or measured at the entry in the cohort such as :
- Clinical factors : age, sex, weight, dosage and time of the last dose
- Biological factors : serum creatinine level, plasma concentration of the drug
- Genetic polymorphisms :
Factor II and CES1 for anti-IIa drugs Factor X, CYP3, CYP3A4, CYP3A5 and ABCG2 for anti-Xa drugs.
By using the same statistical approach and the same variables, predictive factors of either hemorrhagic or thrombotic events will also be evaluated on the whole cohort. The occurence of hemorrhagic and thrombotic complications will then be assessed through a phone call every 3 months during a one-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-IIa users | – | Genetic: PK-PD genetic polymorphismsDetermination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti IIa anticoagulant including analysis of PK-PD genetic polymorphisms |
| Anti-Xa users | – | Genetic: PK-PD genetic polymorphismsDetermination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti Xa anticoagulant including analysis of PK-PD genetic polymorphisms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed by all patient receiving a direct oral anticoagulant inside the University Hospital whatever the clinical indication
Key inclusion criteria (4 listed)
- Patient receiving direct oral anticoagulant
- Complete blood count and measure of hemostasis planned
- Patient able to give consent
- Patient with health insurance
Key exclusion criteria (4 listed)
- Patient not able to consent
- Patient under 18 years old
- Patient refusal
- Patient without health insurance
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 |
|---|---|---|
| PK-PD genetic polymorphismsPK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment | Genetic | Anti-IIa users, Anti-Xa users |
Primary outcome
Measurement of anticoagulant activity level
Time frame: Baseline
Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity
2 secondary outcomes
Occurence of any hemorrhagic complication
Time frame: One year follow-up
Occurence of any thrombotic complication
Time frame: One year follow-up
Results and safety
The study was stopped early (reason given: not sufficiency inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- 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.
Dominique Deplanque, MD, PhD principal investigator
University Hospital, Lille
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 Anticoagulant, run by University Hospital, Lille 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 4 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 18 Oct 2019. 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: not sufficiency inclusion). 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?
Measurement of anticoagulant activity level (time frame: Baseline). 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 18 Oct 2019.