Thromboembolic and Bleeding Risk Stratification in Patients With Non-valvular Atrial Fibrillation (FASTRHAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02741349
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : October 9, 2017
Information provided by (Responsible Party):
Ariel Cohen, Saint Antoine University Hospital

Brief Summary:
The aim of the present prospective study is to further develop and validate a composite risk score predicting both ischemic and bleeding risk, based on epidemiologic, clinical, biological, and/or morphologic complementary data. First, the investigators will assess the predictive performance of current clinical risk scores. Second, the investigators will assess the potential predictive value of additional markers. Third, the investigators will aim to develop a new risk score.

Condition or disease
Atrial Fibrillation

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 825 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Impact of Clinical, Echocardiographic and Biological Parameters to the Risk of Cardiovascular Disease in Patients With Non-valvular Atrial Fibrillation.
Study Start Date : July 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. composite endpoint of all-cause death, acute heart failure, stroke, acute coronary syndrome and major bleeding episode [ Time Frame: two years ]

Secondary Outcome Measures :
  1. incidence of all-cause death [ Time Frame: two years ]
  2. incidence of cardiovascular death [ Time Frame: two years ]
  3. incidence of acute heart failure [ Time Frame: two years ]
  4. incidence of stroke [ Time Frame: two years ]
  5. incidence of acute coronary syndrome [ Time Frame: two years ]
  6. incidence of major bleeding episodes [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
serum bank DNA bank plasma bank copeptin Willebrand factor microparticules ANP

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be composed of patients hospitalized in the Cardiology/Rythmology Department of the recruitment sites for an episode of non-valvular atrial fibrillation during the inclusion period.

Inclusion Criteria:

  • Adults above 18 years of age
  • Presenting a NVAF which is paroxysmal, persistent or permanent and documented by an electrocardiogram (ECG)
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Patients presenting a clinically and echocardiographically significant valve disease defined as :

    • mitral stenosis with a valve area < 2cm2
    • mitral insufficiency (grade 3 or 4)
    • aortic insufficiency (grade 3 or 4)
    • tricuspid insufficiency (grade 3 or 4)
    • aortic stenosis with a valve area < 1.5 cm2
    • mechanical valve prosthèses
  • Secondary AF due to an acute cause (thyrotoxicosis, acute pericarditis, infection, systemic disease)
  • Presence of a contraindication to long term anticoagulant treatment
  • Absence of social security coverage
  • Severe psychiatric history
  • Impossibility of follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02741349

Contact: Ariel Cohen, MD, PhD +33149282886
Contact: Sylvie Lang, PhD +33689742859

Service de cardiologie - hôpital Saint Antoine Recruiting
Paris, France, 75012
Contact: Sylvie Lang, PhD    +33689742859   
Principal Investigator: Ariel Cohen, MD, PhD         
Sub-Investigator: Laurie Soulat Dufour, MD         
Sub-Investigator: Stephane Ederhy, MD         
Service de cadiologie - Hôpital Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Benjamin Bertin    +33142162914   
Principal Investigator: Nadjib Hammoudi, MD         
Centre Cardiologique du Nord Recruiting
Saint-Denis, France, 93200
Contact: Aliocha SCHEUBLE   
Principal Investigator: Aliocha SCHEUBLE, MD         
Service de cardiologie - Clinique Pasteur Recruiting
Toulouse, France, 31300
Contact: Juliette Goutner    +33613731838   
Principal Investigator: Anne-Sophie Beraud, MD         
Sponsors and Collaborators
Saint Antoine University Hospital
Principal Investigator: Ariel Cohen, Md, PhD AP-HP, Hôpital Saint-Antoine, Service de cardiologie, 75012 Paris, France

Responsible Party: Ariel Cohen, Head of the cardiology department, Saint Antoine University Hospital Identifier: NCT02741349     History of Changes
Other Study ID Numbers: 2014-A00280-47
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: each participant can have access to its data by asking the investigator of the study.

Keywords provided by Ariel Cohen, Saint Antoine University Hospital:
Atrial fibrillation
Risk score

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes