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NCT04222868 Clinical Trial

Indonesian Registry on Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— OneAF  

Official title:
Indonesian Registry on Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04222868
Other study ID # InaHRS-2019-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2021

Study information
Verified date January 2020
Source Indonesian Heart Rhythm Society
Contact Sunu B Raharjo, MD, PhD
Phone 6281385044810
Email sunu.b.raharjo@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 30, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia RS Hasan Sadikin Bandung Bandung
Indonesia RS Mitra Keluarga Bekasi Bekasi
Indonesia RS Cirebon CIrebon
Indonesia RS Sanglah Denpasar Denpasar
Indonesia National Cardiovascular Center Harapan Kita Jakarta
Indonesia RS Bina Waluya Jakarta Jakarta
Indonesia RS Pasar Rebo Jakarta Jakarta
Indonesia RS Pusat Pertamina Jakarta Jakarta
Indonesia RS Siloam Kebon Jeruk Jakarta Jakarta
Indonesia RSPAD Gatot Subroto Jakarta Jakarta
Indonesia RSPAU Halim Perdanakusuma Jakarta Jakarta
Indonesia RSUPN Dr.Cipto Mangunkusumo Jakarta
Indonesia RSUP dr. Wahidin Sudirohusodo Makassar Makassar
Indonesia RSUD dr. Saiful Anwar Malang Jawa Timur
Indonesia RSUP Prof. Dr. R. D. Kandou Manado Manado
Indonesia RS Adam Malik Medan Medan
Indonesia Rumah Sakit Umum Pusat Dr. M. Djamil Padang Sumatera Barat
Indonesia RS Muhammad Hoesin Palembang Palembang
Indonesia Eka Hospital Pekan Baru Pekanbaru
Indonesia RSUP dr. Kariadi Semarang Jawa Tengah
Indonesia RSUD Dr. Soetomo Surabaya Surabaya
Indonesia Eka Hospital BSD Tangerang Tangerang
Indonesia RS Siloam Karawaci Tangerang Tangerang
Indonesia RSUD Tangerang Tangerang
Indonesia RS Sardjito Jogjakarta Yogyakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesian Heart Rhythm Society

Country where clinical trial is conducted

Indonesia, 

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