Indonesian Registry on Atrial Fibrillation

• Conditions: Atrial Fibrillation

• Registration Number: NCT04222868
• Lead Sponsor: Indonesian Heart Rhythm Society

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (25)

RSUP dr. Kariadi; 🇮🇩 Semarang, Jawa Tengah, Indonesia

RSUD dr. Saiful Anwar; 🇮🇩 Malang, Jawa Timur, Indonesia

Rumah Sakit Umum Pusat Dr. M. Djamil; 🇮🇩 Padang, Sumatera Barat, Indonesia

RS Hasan Sadikin Bandung; 🇮🇩 Bandung, Indonesia

RS Mitra Keluarga Bekasi; 🇮🇩 Bekasi, Indonesia

RS Cirebon; 🇮🇩 CIrebon, Indonesia

RS Sanglah Denpasar; 🇮🇩 Denpasar, Indonesia

RSUPN Dr.Cipto Mangunkusumo; 🇮🇩 Jakarta, Indonesia

National Cardiovascular Center Harapan Kita; 🇮🇩 Jakarta, Indonesia

RS Bina Waluya Jakarta; 🇮🇩 Jakarta, Indonesia

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