Fimasartan Blood Pressure Lowering After Acute Stroke (FABULOUS)

A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack

This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.

Study Overview

• Status: Completed
• Conditions: Hypertension; Ischemic Stroke; Transient Ischemic Attack

• Study Type: Observational
• Enrollment (Actual): 1035

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Ansan Hospital
  • Anyang, Korea, Republic of
    • Hallym University Medical Center
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of
    • Daejeon Eulji Medical Center
  • Goyang, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Goyang, Korea, Republic of
    • Myongji Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chosun university hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Jeju, Korea, Republic of
    • Jeju National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of
    • Soonchunhyang University Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Medical Center
  • Seoul, Korea, Republic of
    • Inje University Sanggye Paik Hospital
  • Seoul, Korea, Republic of
    • Nowon Eulji Medical Center, Eulji University
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients

Description

Inclusion Criteria:

• Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.
• Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure
• Suitable for administration of fimasartan
• The life expectancy should be over 6 months.

Exclusion Criteria:

• Patients already treated with antihypertensive medications
• Hemorrhagic stroke patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BP	Blood pressure control rate(<140/90 mmHg)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BP	Blood pressure control rate(<140/90 mmHg)	4, 12 weeks
BP	Blood pressure changes	4, 12, 24 weeks
mRS	mRS changes	4, 12, 24 weeks
Fimasartan-based treatment	Fimasartan-based treatment modalities	24 weeks
Fimasartan starting point	Fimasartan starting point after stroke	24 weeks
Stroke recurrence	Rate of stroke recurrence	24 weeks
Cardiovascular events	Incidence of cardiovascular events	24 weeks
Mortality rates from cardiovascular disease	Mortality rates from cardiovascular disease	24 weeks
Mortality rates of any cause	Mortality rates of any cause	24 weeks
Adverse events	Adverse events related to antihypertensive treatments	24 weeks

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Publications and helpful links

General Publications

• Hong KS, Kwon SU, Park JH, Cha JK, Jung JM, Kim YJ, Lee KB, Sohn SI, Lee YS, Rha JH, Kwon JH, Han SW, Kim BJ, Koo J, Choi JC, Sung SM, Lee SJ, Park MS, Ahn SH, Bang OY, Hwang YH, Nam HS, Park JM, Bae HJ, Kim EG, Lee KY, Oh MS. Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia Study. J Clin Neurol. 2021 Jul;17(3):344-353. doi: 10.3988/jcn.2021.17.3.344.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2016
• Primary Completion (Actual): November 2, 2018
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: BR-FMS-OS-401