Clinical trial NCT01104311: Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis
Official title: Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Brain Ischemia
Keywords: Blood Pressure
Atherosclerosis
Brain Ischemia
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-04-15
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)
timeFrame: Screening to 24 weeks
Secondary outcomes:
measure: Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
timeFrame: 24 weeks
measure: The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
timeFrame: 24 weeks
measure: Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
timeFrame: 24 weeks
measure: Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
timeFrame: 24 Week
measure: Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
timeFrame: 24 Weeks
measure: Number of Participants With Adverse Events
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Chungnam
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeonbuk
city: Busan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daejon
country: Korea, Republic of
facility: Eulji University Hospital
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji Hospital
city: Seoul
country: Korea, Republic of
facility: Boramae Hospital
Study officials:
References:
citation: Park JM, Kim BJ, Kwon SU, Hwang YH, Heo SH, Rha JH, Lee J, Park MS, Kim JT, Song HJ, Park JH, Yu S, Lee SJ, Park TH, Cha JK, Kwon HM, Kim EG, Lee SH, Lee JS, Lee J. Intensive blood pressure control may not be safe in subacute ischemic stroke by intracranial atherosclerosis: a result of randomized trial. J Hypertens. 2018 Sep;36(9):1936-1941. doi: 10.1097/HJH.0000000000001784.