The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)

Study Overview
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Brief Summary
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To compare the effect of losartan vs amlodipine-based antihypertensive therapy on atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke patients.

Official Title
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The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: losartan
* Drug: amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient With Tia Or Ischemic Stroke (Event Has Occurred More Thaan 4 Weeks But Less Than 24 Weeks, And Modified Rankin'S Scale, Mrs<=3) With Mild To Moderate Hypertension Patient Has No Other Active Medical Problem, Which Might Of Itself Or By This Treatment Significantly Affect The Patient's Blood Pressure The Blood Level Of Hscrp>0.2 Ng/Dl By Two Measurements Performed Respectively One-Week Apart Exclusion Criteria: Patients With Cardiac Arrhythmia Diabetes Mellitus Patient With Other Active Inflammatory Diseases Such As Rheumatoid Disease, Fever And Systemic Infection Which Will Confound The Level Of Serum CRP Patients With Known Intolerance, Contraindication Or Hypersensitivity To Losartan, Amlodipine and Hydrochlorothiazide Patient With Myocardial Infarction Within The Recent Three Months Anatomy Abnormality Which Results In Poor Bilateral Temporal Acoustic Windows Which Prevent TCD Procedure Patient Who Requires Continuous Medication With Alpha Blocking Agents Concurrent Usage Of Acei Poor Mental Function Or Any Other Reason To Expect Difficulty In Meeting The Requirements Of The Study Concurrent Treatment With Other Lipid-Lowering Drug Childbearing Potential Women Not Undergoing Adequate Contraceptive Control

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Losartan 50mg qd for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics. | Drug: losartan<br>* losartan 50mg qd for 30 weeks.<br>* Other names: MK0954;|
| Active Comparator: B<br>Amlodipine 5 mg q.d for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics. | Drug: amlodipine<br>* amlodipine 5 mg q.d for 30 weeks.<br>* Other names: Norvasc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCAFV and TCD for measuring cerebral autoregulatory indices at week 0, week 6, week 18 and week 30. |  | At week 0, week 6, week 18 and week 30. |