Thromboembolic DiseasesNCT01492777
Pharmacogenetics of Acenocoumarol
An observational study of Thromboembolic Diseases, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolic Diseases
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2008to Mar 2012
- 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: Hospitalized patients starting acenocoumarol therapy
Who may be able to join
- Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- Severe cognitive impairment
- Previous or current treatment with any coumarin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions
The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).
The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.
- Conditions
- Thromboembolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve stable dosing in days, since the beginning of the anticoagulation
Measured: 5 weeks
Secondary outcomes (7)
Number of patients with INR > or = 4.0, which indicates overanticoagulation
Measured: 5 weeks
Time to achieve two consecutive therapeutic INRs
Measured: 5 weeks
Mean daily dosage of acenocoumarol
Measured: 5 weeks
Major bleedings and minor bleedings
Measured: 5 weeks
Thromboembolic events due to infratherapeutic anticoagulation
Measured: 5 weeks
Length of hospitalisation in days
Measured: 5 weeks
Potential of other drug interactions, linked to the observed genotype and phenotype of the patient
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startNov 2008
- Primary completionMar 2011
- Study completionMar 2012
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 Thromboembolic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jules Desmeules, University Hospital, Geneva
- Investigators
- Jules A Desmeules, Prof, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492777
- Sponsor's protocol ID
- CER 08-019
- Status last verified
- Jun 2013
- First submitted
- 13 Dec 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gschwind L, Rollason V, Boehlen F, Rebsamen M, Combescure C, Matthey A, Bonnabry P, Dayer P, Desmeules JA. P-glycoprotein: a clue to vitamin K antagonist stabilization. Pharmacogenomics. 2015 Jan;16(2):129-36. doi: 10.2217/pgs.14.164.
PubMed 25616099
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions
- ClinicalTrials.gov ID
- NCT01492777
- Acronym / sponsor ID
- CER 08-019
- Conditions
- Thromboembolic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Dec 2011 (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 use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).
The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients starting acenocoumarol therapy
Key inclusion criteria (3 listed)
- Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- Previous or current treatment with any coumarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to achieve stable dosing in days, since the beginning of the anticoagulation
Time frame: 5 weeks
7 secondary outcomes
Number of patients with INR > or = 4.0, which indicates overanticoagulation
Time frame: 5 weeks
Time to achieve two consecutive therapeutic INRs
Time frame: 5 weeks
Mean daily dosage of acenocoumarol
Time frame: 5 weeks
Major bleedings and minor bleedings
Time frame: 5 weeks
Thromboembolic events due to infratherapeutic anticoagulation
Time frame: 5 weeks
Length of hospitalisation in days
Time frame: 5 weeks
Potential of other drug interactions, linked to the observed genotype and phenotype of the patient
Time frame: 5 weeks
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 21 Jun 2013.
- Derived from this study: PubMed 25616099Gschwind L, Rollason V, Boehlen F, Rebsamen M, Combescure C, Matthey A, Bonnabry P, Dayer P, Desmeules JA. P-glycoprotein: a clue to vitamin K antagonist stabilization. Pharmacogenomics. 2015 Jan;16(2):129-36. doi: 10.2217/pgs.14.164.
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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.
Jules A Desmeules, Prof principal investigator
University Hospital, Geneva
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 Thromboembolic Diseases, run by University Hospital, Geneva at 1 site in Switzerland.
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 21 Jun 2013. 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 Switzerland. 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?
Time to achieve stable dosing in days, since the beginning of the anticoagulation (time frame: 5 weeks). 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 NCT01492777, 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 21 Jun 2013.