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OpenTrials
Completed

NCT Number: NCT03231293

Fimasartan Blood Pressure Lowering After Acute Stroke

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.

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Key information

Conditions

Hypertension Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Ischemic Stroke Nervous System Diseases Stroke Transient Ischemic Attack Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. BP

    Time frame: 24 weeks

    Blood pressure control rate(<140/90 mmHg)

Secondary outcomes

  1. BP

    Time frame: 4, 12 weeks

    Blood pressure control rate(<140/90 mmHg)

  2. BP

    Time frame: 4, 12, 24 weeks

    Blood pressure changes

  3. mRS

    Time frame: 4, 12, 24 weeks

    mRS changes

  4. Fimasartan-based treatment

    Time frame: 24 weeks

    Fimasartan-based treatment modalities

  5. Fimasartan starting point

    Time frame: 24 weeks

    Fimasartan starting point after stroke

  6. Stroke recurrence

    Time frame: 24 weeks

    Rate of stroke recurrence

  7. Cardiovascular events

    Time frame: 24 weeks

    Incidence of cardiovascular events

  8. Mortality rates from cardiovascular disease

    Time frame: 24 weeks

    Mortality rates from cardiovascular disease

  9. Mortality rates of any cause

    Time frame: 24 weeks

    Mortality rates of any cause

  10. Adverse events

    Time frame: 24 weeks

    Adverse events related to antihypertensive treatments

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Acronym: FABULOUS

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 27, 2017
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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