|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01492777 |
|
Date of registration:
|
13/12/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacogenetics of Acenocoumarol
|
|
Scientific title:
|
Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions |
|
Date of first enrolment:
|
November 2008 |
|
Target sample size:
|
115 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01492777 |
|
Study type:
|
Observational |
|
Study design:
|
Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Jules A Desmeules, Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Geneva |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe cognitive impairment
- Previous or current treatment with any coumarin
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Thromboembolic Diseases
|
|
Primary Outcome(s)
|
|
Time to achieve stable dosing in days, since the beginning of the anticoagulation
[Time Frame: 5 weeks]
|
|
Secondary Outcome(s)
|
|
Time to achieve two consecutive therapeutic INRs
[Time Frame: 5 weeks]
|
|
Potential of other drug interactions, linked to the observed genotype and phenotype of the patient
[Time Frame: 5 weeks]
|
|
Length of hospitalisation in days
[Time Frame: 5 weeks]
|
|
Mean daily dosage of acenocoumarol
[Time Frame: 5 weeks]
|
|
Number of patients with INR > or = 4.0, which indicates overanticoagulation
[Time Frame: 5 weeks]
|
|
Major bleedings and minor bleedings
[Time Frame: 5 weeks]
|
|
Thromboembolic events due to infratherapeutic anticoagulation
[Time Frame: 5 weeks]
|
|
Secondary ID(s)
|
|
CER 08-019
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|