Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-12-31

Brief Summary

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To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke patients with symptomatic severe intracranial atherosclerosis.

Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between 110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis.

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Detailed Description

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The benefits of BP lowering in the prevention of primary and secondary prevention of stroke is established well, although absolute target BP level is uncertain. Current guidelines defined the normal BP as \<120/80mmHg and recommend individualized target BP level.

Large well performed stroke prevention trials consistently showed that reduction of 10/5mmHg in patients with systolic BP below 140mmHg had clear benefits in the prevention of cardiovascular events. However, we have a dilemma about BP control in the patients with severe intracranial atherosclerosis.

Aggressive BP control will be more effective in the prevention of overall cardiovascular events than modest BP control, but aggressive BP control will reduce cerebral perfusion in the territory of severe intracranial disease and may increase the risk of ischemic damage.

The study will try to reveal aggressive BP control in the patients with symptomatic severe intracranial atherosclerosis is not increase ischemic lesion volume in hemisphere to compare modest BP control.

Conditions

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Brain Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aggressive BP lowering

Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period

Group Type EXPERIMENTAL

Aggressive BP lowering

Intervention Type PROCEDURE

adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level

Modest BP lowering

Lowering of systolic blood pressure between 130mmHg and 140mmHg

Group Type ACTIVE_COMPARATOR

modest blood pressure lowering

Intervention Type PROCEDURE

adjust the amount and number of antihypertensive drugs

Interventions

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Aggressive BP lowering

adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level

Intervention Type PROCEDURE

modest blood pressure lowering

adjust the amount and number of antihypertensive drugs

Intervention Type PROCEDURE

Other Intervention Names

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Aggressive BP control Modest BP control

Eligibility Criteria

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Inclusion Criteria

* acute symptomatic ischemic stroke having relevant lesion on DWI(Diffusion weighted image) MRI 7 days after and 42 days within onset.
* relevant stenosis(more than 50%) or occlusion from MCA(middle cerebral artery)(M1) to distal of ICA(internal carotid artery ) on MR(Magnetic resonance) angiogram or CT angiogram.
* mean systolic blood pressure\>=140mmHg or taking antihypertensive drug on screening.

Exclusion Criteria

* taking more than 3 antihypertensive drugs and mean systolic blood pressure\>=150mmHg on screening.
* history of recent thrombolysis but stenosis or occlusion remained after thrombolysis.
* evidence of orthostatic hypotension
* suspicious embolic cerebrovascular stenosis
* planned state of cerebrovascular surgery or angioplasty or stent 7 months within screening.
* severe stroke-NIHSS\>=16
* mean systolic blood pressure\>=200mmHg which is not able to control on screening.
* abnormal blood test finding (abnormal LFT(liver function test), anemia, renal insufficiency)
* pregnant or breast-feeding
* severe stroke sequela or medical problem
* suspicious secondary hypertension
* disease causing edema or significant ankle edema on screening.
* severe heart failure which correspond to NYHA (New York Heart Association )heart failure classification class III or IV.
* inappropriate condition determined by investigator
* Patient who do not have FLAIR image on or two months prior to screening.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No