Optimal intensity of anticoagulation with warfarin in Korean patients with atrial fibrillation: multi-center, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007994

Enrollment

1022

Registered

2022-12-12

Start date

2017-02-23

Completion date

Unknown

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In this randomized, open-label trial, low intensity anticoagulation (INR 1.6 to 2.6) with warfarin was compared with standard intensity anticoagulation (INR 2.0 to 3.0) for the prevention of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? symptomatic non-valvular atrial fibrillation ? high thromboembolic risk patients with CHA2DS2-VASc score = 1 ? provided informed consent for voluntary participation ? no intra-atrial thrombi in transthoracic echocardiogram

Exclusion criteria

Exclusion criteria: ? atrial fibrillation with reversible cause ? valvlar atrial fibrillation ( mitral stenosis more than moderate severity or prosthetic valve replacement) ? acute cerebral infarction within 7 days ? hypersensitivity to warfarin or its constitution ? clinically significant bleeding patient ? increased risk for bleeding A. recent gastrointestinal ulcer bleeding B. recent intracranial bleeding C. intra-spinal cord or intra-cerebral vascular abnormality D. recent spinal cord or cerebral damage E. esophageal varix F. vascular AV malformation G. malignancy with high bleeding risk

Design outcomes

Primary

Measure	Time frame
stroke	—

Secondary

Measure	Time frame
major bleeding	—

Countries

Korea, Republic of

Contacts

Public ContactKi Hong Lee

Chonnam National University Hospital

drgood2@naver.com+82-62-220-6246

Outcome results