NCT04456842

Brief Summary

Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

August 4, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 4, 2024

Status Verified

June 1, 2024

Enrollment Period

4.1 years

First QC Date

June 23, 2020

Last Update Submit

October 3, 2024

Conditions

Atrial FibrillationAtrial Flutter

Keywords

Atrial FibrilationAntithrombotic therapyAtrial Flutter

Outcome Measures

Primary Outcomes (12)

  • INR control rate

    12 months

  • Oral anticoagulation discontinuation rate

    12 months

  • Percentage of death

    12 months

  • Percentage of stroke

    12 months

  • Percentage of systemic embolism

    12 months

  • Percentage of myocardial infarction

    12 months

  • Percentage of major bleeding

    12 months

  • Percentage of electrical cardioversion

    12 months

  • Percentage of percutaneous ablation of AF

    12 months

  • Percentage of atrioventricular junction ablation

    12 months

  • Percentage of patients that need of pacemaker implantation

    12 monts

  • Percentage of other cardiovascular hospitalization

    12 months

Interventions

Patient Registry DataOTHER

To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with Atrial Fibrilation or Atrial Flutter

You may qualify if:

  • Age \> 18 years-old that signed informed consent;
  • If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);

You may not qualify if:

  • Patients who did not agree to participate.
  • Patients without possibility of monitoring for one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hospital Interzonal General de Agudos "Dr. José Penna"

Bahía Blanca, Buenos Aires, Argentina

Location

DIM Clínica Privada

Ramos Mejía, Buenos Aires, Argentina

Location

Centro de Investigaciones Medicas Temperley (CIMeT)

Temperley, Buenos Aires, Argentina

Location

Hospital Italiano de La Plata

Buenos Aires, La Plata, Argentina

Location

Centro Modelo de Cardiologia

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Centro Medico Luquez

Córdoba, Argentina

Location

Prevención Cardiovascular Salta

Salta, Argentina

Location

Servicios Médicos El Castaño

San Juan, Argentina

Location

Instituto Cardiovascular San Luis

San Luis, Argentina

Location

Centro de Investigaciones Clinicas del Litoral SRL

Santa Fe, Argentina

Location

Hospital Provincial Dr. José Maria Cullen

Santa Fe, Argentina

Location

Hospital Alvorada Taguatinga Ltda

São Paulo, Brazil

Location

Sociedad de Cirugia de Bogota - Hospital de San Jose

Bogotá, Cundinamarca, Colombia

Location

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Location

Francisco Gerardo Padilla Padilla

Guadalajara, Jalisco, Mexico

Location

Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)

Querétaro City, Querétaro, Mexico

Location

Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.

Culiacán, Sinaloa, Mexico

Location

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Renato D. Lopes, MD, PhD

    Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 7, 2020

Study Start

August 4, 2020

Primary Completion

September 13, 2024

Study Completion

September 30, 2024

Last Updated

October 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations

AR(11)CO(2)BR(1)ME(3)