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

Phase 4

Terminated

Interventions: Procedure: Aggressive BP lowering
Procedure: modest blood pressure lowering

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Aggressive BP lowering	Aggressive BP lowering	Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Modest BP lowering	modest blood pressure lowering	Lowering of systolic blood pressure between 130mmHg and 140mmHg

Primary Outcome Measures

Name	Time	Method
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)	Screening to 24 weeks	The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI

Secondary Outcome Measures

Name	Time	Method
Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population	24 weeks	the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI	24 weeks
Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.	24 weeks
Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.	24 Week
Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.	24 Weeks
Number of Participants With Adverse Events	24 Weeks	Number of Participants with Adverse Events

Locations (16): Chungnam National University Hospital
🇰🇷
Daejeon, Chungnam, Korea, Republic of
Yeungnam University Hospital
🇰🇷
Daegu, Korea, Republic of
Eulji University Hospital
🇰🇷
Daejon, Korea, Republic of
Inha University Hospital
🇰🇷
Inchon, Korea, Republic of
Kyungpook National University Hospital
🇰🇷
Deagu, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷
Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷
Gwangju, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Eulji Hospital
🇰🇷
Seoul, Korea, Republic of
Boramae Hospital
🇰🇷
Seoul, Korea, Republic of
Myongji Hospital
🇰🇷
Goyang, Gyeonggi-do, Korea, Republic of
Wonkwang University Hospital
🇰🇷
Iksan, Jeonbuk, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷
Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷
Pusan, Korea, Republic of
Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Seoul Medical Center
🇰🇷
Seoul, Korea, Republic of