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

NCT02741349 | Recruiting DMC

• 1 other identifier: 2014-A00280-47
• Study Type: observational
• Target: 825
• Locations: 1 country
• Sites: 4

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Risk score

Outcome Measures

Primary Outcomes (1)

• composite endpoint of all-cause death, acute heart failure, stroke, acute coronary syndrome and major bleeding episode

  two years

Secondary Outcomes (6)

• incidence of all-cause death

  two years

• incidence of cardiovascular death

  two years

• incidence of acute heart failure

  two years

• incidence of stroke

  two years

• incidence of acute coronary syndrome

  two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Antoine University Hospital: lead

Study Sites (4)

Service de cardiologie - hôpital Saint Antoine

Paris, 75012, France

RECRUITING

Service de cadiologie - Hôpital Pitié Salpêtrière

Paris, 75013, France

SUSPENDED

Centre Cardiologique du Nord

Saint-Denis, 93200, France

RECRUITING

Service de cardiologie - Clinique Pasteur

Toulouse, 31300, France

SUSPENDED

Related Publications (1)

• Soulat-Dufour L, Lang S, Addetia K, Ederhy S, Adavane-Scheuble S, Chauvet-Droit M, Jean ML, Nhan P, Ben Said R, Kamami I, Issaurat P, Capderou E, Arnaud C, Boccara F, Lang RM, Cohen A. Restoring Sinus Rhythm Reverses Cardiac Remodeling and Reduces Valvular Regurgitation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2022 Mar 15;79(10):951-961. doi: 10.1016/j.jacc.2021.12.029.

  PMID: 35272799 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum bank DNA bank plasma bank copeptin Willebrand factor microparticules ANP

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ariel Cohen, Md, PhD

  AP-HP, Hôpital Saint-Antoine, Service de cardiologie, 75012 Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Cohen, MD, PhD

CONTACT

+33149282886; ariel.cohen@aphp.fr

Sylvie Lang, PhD

CONTACT

+33689742859; sylvie.lang@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the cardiology department

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 18, 2016
• Study Start: July 27, 2015
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)