Indonesian Registry on Atrial Fibrillation (OneAF)

January 14, 2020 updated by: Indonesian Heart Rhythm Society
Our rationale of creation of this registry stems from the fact that the use of VKA in patients with AF is a double-edged sword, physicians face tremendous burden in assigning patients with VKA, due to risk of Bleeding complications despite its potential benefit. We intend to seek a safe and beneficial range of INR on Indonesian patients.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Bandung, Indonesia
        • Recruiting
        • RS Hasan Sadikin Bandung
        • Contact:
        • Principal Investigator:
          • Chaerul Achmad
      • Bekasi, Indonesia
        • Recruiting
        • RS Mitra Keluarga Bekasi
        • Contact:
      • CIrebon, Indonesia
      • Denpasar, Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • RSUPN Dr.Cipto Mangunkusumo
        • Contact:
        • Sub-Investigator:
          • Simon Salim
      • Jakarta, Indonesia, 11420
        • Recruiting
        • National Cardiovascular Center Harapan Kita
        • Contact:
        • Sub-Investigator:
          • Yoga Yuniadi, Prof MD PhD
        • Sub-Investigator:
          • Dicky A Hanafy, MD
        • Sub-Investigator:
          • Dony Y Hermanto, MD
        • Sub-Investigator:
          • Andien Munawar
      • Jakarta, Indonesia
        • Recruiting
        • RS Bina Waluya Jakarta
        • Contact:
        • Sub-Investigator:
          • Beny Hartono
      • Jakarta, Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • RS Pusat Pertamina Jakarta
        • Contact:
      • Jakarta, Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • RSPAD Gatot Subroto Jakarta
        • Contact:
          • Farial Indra
        • Sub-Investigator:
          • Agus Harsoyo
      • Jakarta, Indonesia
        • Recruiting
        • RSPAU Halim Perdanakusuma Jakarta
        • Contact:
          • Adhantoro Rahadyan
      • Makassar, Indonesia
        • Recruiting
        • RSUP dr. Wahidin Sudirohusodo Makassar
        • Contact:
      • Manado, Indonesia
      • Medan, Indonesia
        • Recruiting
        • RS Adam Malik Medan
        • Contact:
          • Anggia Lubis
      • Palembang, Indonesia
      • Pekanbaru, Indonesia
      • Surabaya, Indonesia
        • Recruiting
        • RSUD Dr. Soetomo Surabaya
        • Contact:
        • Principal Investigator:
          • Budi Baktijasa
      • Tangerang, Indonesia
      • Tangerang, Indonesia
      • Tangerang, Indonesia
      • Yogyakarta, Indonesia
    • Jawa Tengah
      • Semarang, Jawa Tengah, Indonesia, 50244
    • Jawa Timur
      • Malang, Jawa Timur, Indonesia, 65111
        • Recruiting
        • RSUD Dr. Saiful Anwar
        • Contact:
    • Sumatera Barat
      • Padang, Sumatera Barat, Indonesia, 25171
        • Recruiting
        • Rumah Sakit Umum Pusat Dr. M. Djamil
        • Contact:
          • Hauda E Rasyid, MD
          • Phone Number: +6287880027663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is an observational study on AF registry, in which all AF patients in our hospitals that fulfilled inclusion and exclusion criteria will be input as respondents to the registry. There are two respondents for this registry, cohort, and no cohort. Noncohort registry respondents are AF patients at hospitals who fulfilled inclusion and exclusion criteria who did not consent for a 24 month follow up. Baseline characteristics of these respondents will be put to eCRF according to their hospital medical records. Patients who fulfilled inclusion and exclusion criteria who consented for a 24 month follow up were called cohort registry respondent. These respondents will be followed up at 6th, 12th and 24th month.

Description

Inclusion Criteria:

  • Age >18 years old
  • Diagnosis of valvular or nonvalvular AF

Exclusion Criteria:

  • Reversible AF
  • Patients who have been enrolled as a respondent on other clinical studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Major Adverse Cardiovascular Events
Time Frame: 24 months
Major Adverse Cardiovascular Events including stroke/transient ischemic attack, thromboembolism, acute coronary syndrome
24 months
Number of Participants with Bleeding Events
Time Frame: 24 months
Intracranial bleeding, gastrointestinal bleeding
24 months
Mortality Rate
Time Frame: 24 months
All-cause Mortality
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesian Heart Rhythm Society

Investigators

  • Principal Investigator: Sunu B Raharjo, MD, PhD, Indonesia-MoH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InaHRS-2019-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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