Fimasartan Blood Pressure Lowering After Acute Stroke

Completed

• Conditions: Ischemic Stroke; Hypertension; Transient Ischemic Attack

• Registration Number: NCT03231293
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-28
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Primary Completion: 2018-11-02
• Study Completion: 2019-04-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BP	24 weeks	Blood pressure control rate(\<140/90 mmHg)

Secondary Outcome Measures

Name	Time	Method
Fimasartan-based treatment	24 weeks	Fimasartan-based treatment modalities
Fimasartan starting point	24 weeks	Fimasartan starting point after stroke
Mortality rates of any cause	24 weeks	Mortality rates of any cause
Adverse events	24 weeks	Adverse events related to antihypertensive treatments
mRS	4, 12, 24 weeks	mRS changes
Cardiovascular events	24 weeks	Incidence of cardiovascular events
Mortality rates from cardiovascular disease	24 weeks	Mortality rates from cardiovascular disease
Stroke recurrence	24 weeks	Rate of stroke recurrence
BP	4, 12, 24 weeks	Blood pressure changes

Trial Locations

Locations (27)

Korea University Ansan Hospital; 🇰🇷 Ansan, Korea, Republic of

Hallym University Medical Center; 🇰🇷 Anyang, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Daejeon Eulji Medical Center; 🇰🇷 Daejeon, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang, Korea, Republic of

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