Atrial FibrillationCOAGFAIINCT01224574
To Assess the Predictive Value of D-dimer Level on the Occurrence of Cardiovascular Events
An observational study of Atrial Fibrillation, run by Hopital Lariboisière at 1 site in France.
Trial summary
The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 425 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2001to Jul 2007
- 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: Patients with atrial fibrillation encountered in usual care
Who may be able to join
- atrial fibrillation
Who cannot join
- follow-up not possible, poor prognosis within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques
The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.
Read the detailed description
Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fribrillation, cardiovascular events, aging, D-dimer
- Medical subject headings
- Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJan 2001
- Primary completionJul 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Isabelle Mahé, MD,PhD, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224574
- Sponsor's protocol ID
- AOR 01 029
- Acronym
- COAGFAII
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahe I, Drouet L, Simoneau G, Minh-Muzeaux S, Caulin C, Bergmann JF. D-dimer can predict survival in patients with chronic atrial fibrillation. Blood Coagul Fibrinolysis. 2004 Jul;15(5):413-7. doi: 10.1097/01.mbc.0000114440.81125.bd.
PubMed 15205590Mahe I, Drouet L, Chassany O, Mazoyer E, Simoneau G, Knellwolf AL, Caulin C, Bergmann JF. D-dimer: a characteristic of the coagulation state of each patient with chronic atrial fibrillation. Thromb Res. 2002 Jul 15;107(1-2):1-6. doi: 10.1016/s0049-3848(02)00184-6.
PubMed 12413581Mahe I, Grenard AS, Joyeux N, Caulin C, Bergmann JF. Management of oral anticoagulant in clinical practice: a retrospective study of 187 patients. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1339-42. doi: 10.1093/gerona/59.12.1339.
PubMed 15699536Lafuente-Lafuente C, Mahe I, Extramiana F. Management of atrial fibrillation. BMJ. 2009 Dec 23;339:b5216. doi: 10.1136/bmj.b5216. No abstract available.
PubMed 20032065
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques
- ClinicalTrials.gov ID
- NCT01224574
- Acronym / sponsor ID
- COAGFAII / AOR 01 029
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fribrillation, cardiovascular events, aging, D-dimer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2001
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Oct 2010 (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 primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.
Detailed description
Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation encountered in usual care
Key inclusion criteria (1 listed)
- atrial fibrillation
Key exclusion criteria (1 listed)
- follow-up not possible, poor prognosis within 3 months
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
Not reported in the source record.
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 20 Oct 2010.
- Background: PubMed 15205590Mahe I, Drouet L, Simoneau G, Minh-Muzeaux S, Caulin C, Bergmann JF. D-dimer can predict survival in patients with chronic atrial fibrillation. Blood Coagul Fibrinolysis. 2004 Jul;15(5):413-7. doi: 10.1097/01.mbc.0000114440.81125.bd.
- Background: PubMed 12413581Mahe I, Drouet L, Chassany O, Mazoyer E, Simoneau G, Knellwolf AL, Caulin C, Bergmann JF. D-dimer: a characteristic of the coagulation state of each patient with chronic atrial fibrillation. Thromb Res. 2002 Jul 15;107(1-2):1-6. doi: 10.1016/s0049-3848(02)00184-6.
- Background: PubMed 15699536Mahe I, Grenard AS, Joyeux N, Caulin C, Bergmann JF. Management of oral anticoagulant in clinical practice: a retrospective study of 187 patients. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1339-42. doi: 10.1093/gerona/59.12.1339.
- Background: PubMed 20032065Lafuente-Lafuente C, Mahe I, Extramiana F. Management of atrial fibrillation. BMJ. 2009 Dec 23;339:b5216. doi: 10.1136/bmj.b5216. No abstract available.
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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.
Isabelle Mahé, MD,PhD principal investigator
Hopital Lariboisière
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 Atrial Fibrillation, run by Hopital Lariboisière 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 1 inclusion and 1 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 20 Oct 2010. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224574, which also lists 4 linked publications.
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 20 Oct 2010.