ARCHIMED VILLE - Prevention of venous thromboembolic events with Arixtra 2.5mg for medical ill patients in general practice 
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 01/01/2020 | Version : 1 | ID : 142
| General | |
| Identification | |
| Detailed name | Prevention of venous thromboembolic events with Arixtra 2.5mg for medical ill patients in general practice |
| Sign or acronym | ARCHIMED VILLE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 906318 |
| General Aspects | |
| Medical area |
General practice |
| Others (details) | venous thromboembolic events |
| Keywords | pharmaco-epidemiology, thrombosis, fondaparinux, arixtra |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | LABORATOIRE GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Investigators will be selected via random drawing using a complete sampling frame of the general practitioners exercising in metropolitan France. He will complete a specific inclusion questionnaire for the first 3 patients that meet the eligibility criteria. |
| Database objective | |
| Main objective | Evaluate the average duration of treatment via ARIXTRA® 2.5 mg with thromboprophylaxis in ambulatory general practice |
| Inclusion criteria |
Patient of at least 18 years of age, -bedridden or with reduced mobility, -for whom a treatment via ARIXTRA® 2.5 mg is initiated with thromboprophylaxis. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 834 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Throughout the entire duration of the study, the doctor will log the prescriptions of ARIXTRA® 2,.5 mg for thromboprophylaxis in a registry. This registry will make it possible to evaluate prescription volume and the representativeness of the patients effectively included in the study. The doctor will complete for each patient included a follow-up questionnaire at the end of treatment. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | The data that will be collected in the follow-up questionnaire are: • Premature interruption of the treatment, • total duration of the administration of the treatment, • prescriptions for prophylactic purposes after the treatment. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications in progress |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
