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

Taipei Veterans General Hospital

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke

Treatments: Drug: amlodipine; Drug: losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00754429

MK0954-338

2008_025

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A

Experimental group

Description:

Losartan 50mg qd for 30 weeks, if blood pressure \> 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.

Treatment:

Drug: losartan

B

Active Comparator group

Description:

Amlodipine 5 mg q.d for 30 weeks, if blood pressure \> 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.

Treatment:

Drug: amlodipine