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Fimasartan Blood Pressure Lowering After Acute Stroke (FABULOUS)

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ClinicalTrials.gov Identifier: NCT03231293
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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.

Condition or disease
Hypertension Ischemic Stroke Transient Ischemic Attack

Study Type : Observational
Estimated Enrollment : 1032 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 28, 2016
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Blood pressure control rate(<140/90 mmHg) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Blood pressure control rate(<140/90 mmHg) [ Time Frame: 4, 12 weeks ]
  2. Blood pressure changes [ Time Frame: 4, 12, 24 weeks ]
  3. mRS changes [ Time Frame: 4, 12, 24 weeks ]
  4. Fimasartan-based treatment modalities [ Time Frame: 24 weeks ]
  5. Fimasartan starting point after stroke [ Time Frame: 24 weeks ]
  6. Rate of stroke recurrence [ Time Frame: 24 weeks ]
  7. Incidence of cardiovascular events [ Time Frame: 24 weeks ]
  8. Mortality rates from cardiovascular disease [ Time Frame: 24 weeks ]
  9. Mortality rates of any cause [ Time Frame: 24 weeks ]
  10. Adverse events related to antihypertensive treatments [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231293

Contact: Sun U Kwon, MD 02-3010-3440 sunkwon7@gmail.com

Korea, Republic of
Severance Hospital Recruiting
Seodaemun-gu, Seoul, Korea, Republic of, 03722
Contact: Hyo S Nam, MD    02-2228-1617    HSNAM@yuhs.ac   
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03231293     History of Changes
Other Study ID Numbers: BR-FMS-OS-401
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia