Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-01 @ 7:54 PM
Study NCT ID:
NCT04222868
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2020-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indonesian Registry on Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Major Adverse Cardiovascular Events', 'timeFrame': '24 months', 'description': 'Major Adverse Cardiovascular Events including stroke/transient ischemic attack, thromboembolism, acute coronary syndrome'}, {'measure': 'Number of Participants with Bleeding Events', 'timeFrame': '24 months', 'description': 'Intracranial bleeding, gastrointestinal bleeding'}, {'measure': 'Mortality Rate', 'timeFrame': '24 months', 'description': 'All-cause Mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'registry', 'anticoagulant'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '34106597', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old\n* Diagnosis of valvular or nonvalvular AF\n\nExclusion Criteria:\n\n* Reversible AF\n* Patients who have been enrolled as a respondent on other clinical studies'}, 'identificationModule': {'nctId': 'NCT04222868', 'acronym': 'OneAF', 'briefTitle': 'Indonesian Registry on Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Indonesian Heart Rhythm Society'}, 'officialTitle': 'Indonesian Registry on Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'InaHRS-2019-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '50244', 'city': 'Semarang', 'state': 'Central Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Pipin Ardhianto, MD', 'role': 'CONTACT', 'email': 'pipin_ardhianto@yahoo.com', 'phone': '+62248442266'}], 'facility': 'RSUP dr. Kariadi', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}, {'zip': '65111', 'city': 'Malang', 'state': 'East Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Ardian Rizal, MD', 'role': 'CONTACT', 'email': 'drardianrizal@gmail.com', 'phone': '628179651252'}], 'facility': 'RSUD dr. Saiful Anwar', 'geoPoint': {'lat': -7.9797, 'lon': 112.6304}}, {'zip': '25171', 'city': 'Padang', 'state': 'West Sumatra', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Hauda E Rasyid, MD', 'role': 'CONTACT', 'phone': '+6287880027663'}], 'facility': 'Rumah Sakit Umum Pusat Dr. M. Djamil', 'geoPoint': {'lat': -0.94924, 'lon': 100.35427}}, {'city': 'Bandung', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Muhammad Iqbal', 'role': 'CONTACT', 'email': 'mohammadiqbal178@gmail.com'}, {'name': 'Chaerul Achmad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RS Hasan Sadikin Bandung', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}, {'city': 'Bekasi', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Faris Basalamah', 'role': 'CONTACT', 'email': 'fbslmh@yahoo.com'}], 'facility': 'RS Mitra Keluarga Bekasi', 'geoPoint': {'lat': -6.2349, 'lon': 106.9896}}, {'city': 'Cirebon', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Doni Friadi', 'role': 'CONTACT', 'email': 'doni.friadi@gmail.com'}], 'facility': 'RS Cirebon', 'geoPoint': {'lat': -6.7063, 'lon': 108.557}}, {'city': 'Denpasar', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'I Made Putra S Antara', 'role': 'CONTACT', 'email': 'anakbali@gmail.com'}], 'facility': 'RS Sanglah Denpasar', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}, {'zip': '10430', 'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Muhammad Yamin, MD PhD', 'role': 'CONTACT', 'email': 'muhyam511@gmail.com', 'phone': '628129787345'}, {'name': 'Simon Salim', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'RSUPN Dr.Cipto Mangunkusumo', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '11420', 'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Sunu B Raharjo, MD, PhD', 'role': 'CONTACT', 'email': 'sunu.b.raharjo@gmail.com', 'phone': '6281385044810'}, {'name': 'Yoga Yuniadi, Prof MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dicky A Hanafy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dony Y Hermanto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andien Munawar', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cardiovascular Center Harapan Kita', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Muhammad Munawar, MD, PhD', 'role': 'CONTACT', 'email': 'muna286@gmail.com'}, {'name': 'Beny Hartono', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'RS Bina Waluya Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Agung F Chandranegara', 'role': 'CONTACT', 'email': 'chandranegara01@gmail.com'}], 'facility': 'RS Pasar Rebo Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Hermawan Hermawan', 'role': 'CONTACT', 'email': 'radyazka@yahoo.com'}], 'facility': 'RS Pusat Pertamina Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Reynold Agustinus', 'role': 'CONTACT', 'email': 'reynold.agustinus@gmail.com'}], 'facility': 'RS Siloam Kebon Jeruk Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Farial Indra', 'role': 'CONTACT'}, {'name': 'Agus Harsoyo', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'RSPAD Gatot Subroto Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Adhantoro Rahadyan', 'role': 'CONTACT'}], 'facility': 'RSPAU Halim Perdanakusuma Jakarta', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Makassar', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Muzakkir Muzakkir', 'role': 'CONTACT', 'email': 'dr.muzakkir@gmail.com'}], 'facility': 'RSUP dr. Wahidin Sudirohusodo Makassar', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}, {'city': 'Manado', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Benny M Setiadi', 'role': 'CONTACT', 'email': 'setiadibenny82@gmail.com'}], 'facility': 'RSUP Prof. Dr. R. D. Kandou Manado', 'geoPoint': {'lat': 1.48218, 'lon': 124.84892}}, {'city': 'Medan', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Anggia Lubis', 'role': 'CONTACT'}], 'facility': 'RS Adam Malik Medan', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}, {'city': 'Palembang', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Alexander E Tondas', 'role': 'CONTACT', 'email': 'tondas2000@gmail.com'}], 'facility': 'RS Muhammad Hoesin Palembang', 'geoPoint': {'lat': -2.91673, 'lon': 104.7458}}, {'city': 'Pekanbaru', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Haryadi Haryadi', 'role': 'CONTACT', 'email': 'mdhary95@gmail.com'}], 'facility': 'Eka Hospital Pekan Baru', 'geoPoint': {'lat': 0.51667, 'lon': 101.44167}}, {'city': 'Surabaya', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Rerdin Julario', 'role': 'CONTACT', 'email': 'rerdinjulario@gmail.com'}, {'name': 'Budi Baktijasa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RSUD Dr. Soetomo Surabaya', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}, {'city': 'Tangerang', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Daniel Tanubudi', 'role': 'CONTACT', 'email': 'dtanubudi@gmail.com'}], 'facility': 'Eka Hospital BSD Tangerang', 'geoPoint': {'lat': -6.17806, 'lon': 106.63}}, {'city': 'Tangerang', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Antonia A Lukito', 'role': 'CONTACT', 'email': 'lukito_ant@yahoo.com'}], 'facility': 'RS Siloam Karawaci Tangerang', 'geoPoint': {'lat': -6.17806, 'lon': 106.63}}, {'city': 'Tangerang', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Ignatius Yansen', 'role': 'CONTACT', 'email': 'ignatius.yansen@gmail.com'}], 'facility': 'RSUD Tangerang', 'geoPoint': {'lat': -6.17806, 'lon': 106.63}}, {'city': 'Yogyakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Erika Maharani', 'role': 'CONTACT', 'email': 'erikamaharyo@yahoo.com'}], 'facility': 'RS Sardjito Jogjakarta', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}], 'centralContacts': [{'name': 'Sunu B Raharjo, MD, PhD', 'role': 'CONTACT', 'email': 'sunu.b.raharjo@gmail.com', 'phone': '6281385044810'}], 'overallOfficials': [{'name': 'Sunu B Raharjo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia-MoH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesian Heart Rhythm Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}