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

Phase 4

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: amlodipine; Drug: losartan

• Registration Number: NCT00754429
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	amlodipine	Amlodipine 5 mg q.d for 30 weeks, if blood pressure \> 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.
A	losartan	Losartan 50mg qd for 30 weeks, if blood pressure \> 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.

Primary Outcome Measures

Name	Time	Method
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.