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Fimasartan Blood Pressure Lowering After Acute Stroke

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03231293
Acronym
FABULOUS
Enrollment
1035
Registered
2017-07-27
Start date
2016-07-28
Completion date
2019-04-05
Last updated
2019-11-04

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

Conditions

Hypertension, Ischemic Stroke, Transient Ischemic Attack

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.

Interventions

None listed

Sponsors

Boryung Pharmaceutical Co., Ltd
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BP24 weeksBlood pressure control rate(\<140/90 mmHg)

Secondary

MeasureTime frameDescription
mRS4, 12, 24 weeksmRS changes
Fimasartan-based treatment24 weeksFimasartan-based treatment modalities
Fimasartan starting point24 weeksFimasartan starting point after stroke
Stroke recurrence24 weeksRate of stroke recurrence
BP4, 12 weeksBlood pressure control rate(\<140/90 mmHg)
Mortality rates from cardiovascular disease24 weeksMortality rates from cardiovascular disease
Mortality rates of any cause24 weeksMortality rates of any cause
Adverse events24 weeksAdverse events related to antihypertensive treatments
Cardiovascular events24 weeksIncidence of cardiovascular events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026