Atrial FibrillationOneAFNCT04222868
Indonesian Registry on Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Indonesian Heart Rhythm Society at 25 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 25 sitesIndonesia
- Study dates
- 1 Jan 2019to 30 Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >18 years old
- Diagnosis of valvular or nonvalvular AF
Who cannot join
- Reversible AF
- Patients who have been enrolled as a respondent on other clinical studies
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Indonesia25 sites, 25 recruiting
- Recruiting
RS Hasan Sadikin Bandung
Bandung
Muhammad Iqbal, mohammadiqbal178@gmail.com
Chaerul Achmad
- Recruiting
RS Mitra Keluarga Bekasi
Bekasi
Faris Basalamah, fbslmh@yahoo.com
- Recruiting
RS Cirebon
Cirebon
Doni Friadi, doni.friadi@gmail.com
- Recruiting
RS Sanglah Denpasar
Denpasar
I Made Putra S Antara, anakbali@gmail.com
- Recruiting
RSUPN Dr.Cipto Mangunkusumo
Jakarta, 10430
Muhammad Yamin, MD PhD, 628129787345, muhyam511@gmail.com
Simon Salim
- Recruiting
National Cardiovascular Center Harapan Kita
Jakarta, 11420
Sunu B Raharjo, MD, PhD, 6281385044810, sunu.b.raharjo@gmail.com
Yoga Yuniadi, Prof MD PhD
- Recruiting
RS Bina Waluya Jakarta
Jakarta
Muhammad Munawar, MD, PhD, muna286@gmail.com
Beny Hartono
- Recruiting
RS Pasar Rebo Jakarta
Jakarta
Agung F Chandranegara, chandranegara01@gmail.com
- Recruiting
RS Pusat Pertamina Jakarta
Jakarta
Hermawan Hermawan, radyazka@yahoo.com
- Recruiting
RS Siloam Kebon Jeruk Jakarta
Jakarta
Reynold Agustinus, reynold.agustinus@gmail.com
- Recruiting
RSPAD Gatot Subroto Jakarta
Jakarta
Farial Indra
Agus Harsoyo
- Recruiting
RSPAU Halim Perdanakusuma Jakarta
Jakarta
Adhantoro Rahadyan
- Recruiting
RSUP dr. Wahidin Sudirohusodo Makassar
Makassar
Muzakkir Muzakkir, dr.muzakkir@gmail.com
- Recruiting
RSUD dr. Saiful Anwar
Malang, East Java, 65111
Ardian Rizal, MD, 628179651252, drardianrizal@gmail.com
- Recruiting
RSUP Prof. Dr. R. D. Kandou Manado
Manado
Benny M Setiadi, setiadibenny82@gmail.com
- Recruiting
RS Adam Malik Medan
Medan
Anggia Lubis
- Recruiting
Rumah Sakit Umum Pusat Dr. M. Djamil
Padang, West Sumatra, 25171
Hauda E Rasyid, MD, +6287880027663
- Recruiting
RS Muhammad Hoesin Palembang
Palembang
Alexander E Tondas, tondas2000@gmail.com
- Recruiting
Eka Hospital Pekan Baru
Pekanbaru
Haryadi Haryadi, mdhary95@gmail.com
- Recruiting
RSUP dr. Kariadi
Semarang, Central Java, 50244
Pipin Ardhianto, MD, +62248442266, pipin_ardhianto@yahoo.com
- Recruiting
RSUD Dr. Soetomo Surabaya
Surabaya
Rerdin Julario, rerdinjulario@gmail.com
Budi Baktijasa
- Recruiting
Eka Hospital BSD Tangerang
Tangerang
Daniel Tanubudi, dtanubudi@gmail.com
- Recruiting
RS Siloam Karawaci Tangerang
Tangerang
Antonia A Lukito, lukito_ant@yahoo.com
- Recruiting
RSUD Tangerang
Tangerang
Ignatius Yansen, ignatius.yansen@gmail.com
- Recruiting
RS Sardjito Jogjakarta
Yogyakarta
Erika Maharani, erikamaharyo@yahoo.com
About this study
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.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, registry, anticoagulant
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Major Adverse Cardiovascular Events
Major Adverse Cardiovascular Events including stroke/transient ischemic attack, thromboembolism, acute coronary syndrome
Measured: 24 months
Number of Participants with Bleeding Events
Intracranial bleeding, gastrointestinal bleeding
Measured: 24 months
Mortality Rate
All-cause Mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Jan 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Indonesian Heart Rhythm Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunu B Raharjo, MD, PhD, Principal investigator, Indonesia-MoH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222868
- Sponsor's protocol ID
- InaHRS-2019-001
- Acronym
- OneAF
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34106597
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indonesian Registry on Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04222868
- Acronym / sponsor ID
- OneAF / InaHRS-2019-001
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, registry, anticoagulant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Indonesian Heart Rhythm SocietyUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age >18 years old
- Diagnosis of valvular or nonvalvular AF
Key exclusion criteria (2 listed)
- Reversible AF
- Patients who have been enrolled as a respondent on other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Number of Participants with Bleeding Events
Time frame: 24 months
Intracranial bleeding, gastrointestinal bleeding
Mortality Rate
Time frame: 24 months
All-cause Mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 34106597Raharjo 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunu B Raharjo, MD, PhD principal investigator
Indonesia-MoH
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Indonesian Heart Rhythm Society at 25 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sunu B Raharjo, MD, PhD (6281385044810, sunu.b.raharjo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Major Adverse Cardiovascular Events (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04222868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.