Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea

Stroke Clinical Trial

Official title:

Quality of Anticoagulation With Warfarin in Patient With Atrial Fibrillation for Secondary Stroke Prevention in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810509
• Other study ID #: Warfarin TTR-01
• Status: Completed
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2018
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current study aims to assess the quality of anticoagulation with warfarin in real world practice of secondary stroke prevention in Korean patients with Atrial fibrillation (AF) and to explore predictors for poor International Normalized Range (INR) control.

Description:

• To assess the quality of anticoagulation with warfarin in real world practice of Korea for secondary stroke prevention in patients with AF-related Cardioembolic (CE) stroke 1) who initiated warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period (warfarin-initiated cohort), and 2) who initiated and maintained warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period (long-term warfarin-treated cohort).

• To explore predictors for poor INR control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1814
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Inclusion criteria for the warfarin-initiated cohort

1. Admission due to AF-related ischemic stroke

2. Initiation of warfarin therapy and treatment at least for more than 7 days of warfarin adjustment period

3. For TTR calculation, available consecutive INR values =3 after the 7 days of warfarin adjustment

Inclusion criteria for the long-term warfarin-treated cohort

1. Admission due to AF-related ischemic stroke

2. Long-term warfarin therapy at least for more than 90 days after the 7 days of warfarin adjustment period

3. For TTR calculation, available consecutive INR values =3 after the 7 days of warfarin adjustment

4. TTR evaluable days = 90 days

Exclusion Criteria:

1. AF with mechanical valve

2. Enrollment in anticoagulation randomized clinical trial

3. Enrollment in studies affecting the target INR range.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Hallym University College of Medicine	Anyang
Korea, Republic of	Dong-A University College of Medicine	Busan
Korea, Republic of	Yeungnam University School of Medicine	Daegu
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang
Korea, Republic of	Chonnam National University Medical School	Gwangju
Korea, Republic of	Ilsan Paik Hospital Inje University	Ilsan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Jeju National University Hospital, Jeju National University College of Medicine	Jeju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Eulji General Hospital, Eulji University School of Medicine	Seoul
Korea, Republic of	Korea University College of Medicine	Seoul
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Seoul National University College of Medicine	Seoul
Korea, Republic of	Soonchunhyang University	Seoul
Korea, Republic of	Soonchunhyang University College of Medicine	Seoul
Korea, Republic of	University of Ulsan College of Medicine	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.	The primary outcome is TTR as measured by the percentage of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.	We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)
Secondary	Percentage of INR Values in the Therapeutic Range of 2.0-3.0: Numbers of INR Values Within the Therapeutic Range by the Total Numbers of INR Measured.	The secondary outcome is the percentage of INR values in the therapeutic range of 2.0-3.0: numbers of INR values within the therapeutic range divided by the total numbers of INR measured.	We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)