Clinical trial NCT03231293: Fimasartan Blood Pressure Lowering After Acute Stroke
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Ischemic Stroke
Transient Ischemic Attack
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 1035
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: BP
timeFrame: 24 weeks
Secondary outcomes:
measure: BP
timeFrame: 4, 12 weeks
measure: BP
timeFrame: 4, 12, 24 weeks
measure: mRS
timeFrame: 4, 12, 24 weeks
measure: Fimasartan-based treatment
timeFrame: 24 weeks
measure: Fimasartan starting point
timeFrame: 24 weeks
measure: Stroke recurrence
timeFrame: 24 weeks
measure: Cardiovascular events
timeFrame: 24 weeks
measure: Mortality rates from cardiovascular disease
timeFrame: 24 weeks
measure: Mortality rates of any cause
timeFrame: 24 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Myung Sook Hong
role: STUDY_DIRECTOR
References:
citation: 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.