Clinical trial NCT04222868: Indonesian Registry on Atrial Fibrillation
Official title: Indonesian Registry on Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
registry
anticoagulant
Lead sponsor: Indonesian Heart Rhythm Society
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Major Adverse Cardiovascular Events
timeFrame: 24 months
measure: Number of Participants with Bleeding Events
timeFrame: 24 months
measure: Mortality Rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: RSUP dr. Kariadi
state: Jawa Tengah
city: Malang
country: Indonesia
facility: RSUD dr. Saiful Anwar
state: Jawa Timur
city: Padang
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. M. Djamil
state: Sumatera Barat
city: Bandung
country: Indonesia
facility: RS Hasan Sadikin Bandung
city: Bekasi
country: Indonesia
facility: RS Mitra Keluarga Bekasi
city: CIrebon
country: Indonesia
facility: RS Cirebon
city: Denpasar
country: Indonesia
facility: RS Sanglah Denpasar
city: Jakarta
country: Indonesia
facility: RSUPN Dr.Cipto Mangunkusumo
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
city: Jakarta
country: Indonesia
facility: RS Bina Waluya Jakarta
city: Jakarta
country: Indonesia
facility: RS Pasar Rebo Jakarta
city: Jakarta
country: Indonesia
facility: RS Pusat Pertamina Jakarta
city: Jakarta
country: Indonesia
facility: RS Siloam Kebon Jeruk Jakarta
city: Jakarta
country: Indonesia
facility: RSPAD Gatot Subroto Jakarta
city: Jakarta
country: Indonesia
facility: RSPAU Halim Perdanakusuma Jakarta
city: Makassar
country: Indonesia
facility: RSUP dr. Wahidin Sudirohusodo Makassar
city: Manado
country: Indonesia
facility: RSUP Prof. Dr. R. D. Kandou Manado
city: Medan
country: Indonesia
facility: RS Adam Malik Medan
city: Palembang
country: Indonesia
facility: RS Muhammad Hoesin Palembang
city: Pekanbaru
country: Indonesia
facility: Eka Hospital Pekan Baru
city: Surabaya
country: Indonesia
facility: RSUD Dr. Soetomo Surabaya
city: Tangerang
country: Indonesia
facility: Eka Hospital BSD Tangerang
city: Tangerang
country: Indonesia
facility: RS Siloam Karawaci Tangerang
city: Tangerang
country: Indonesia
facility: RSUD Tangerang
city: Yogyakarta
country: Indonesia
facility: RS Sardjito Jogjakarta
Study officials:
affiliation: Indonesia-MoH
name: Sunu B Raharjo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raharjo SB, Chandranegara AF, Hanafy DA, Yamin M, Rasyid HE, Haryadi, Rizal A, Ardhianto P, Hermanto DY, Yuniadi Y; OneAF Investigators. Indonesian registry on atrial fibrillation (OneAF). Medicine (Baltimore). 2021 May 14;100(19):e25725. doi: 10.1097/MD.0000000000025725.