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Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis (STABLE-ICAS)

Primary Purpose

Brain Ischemia

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aggressive BP lowering
modest blood pressure lowering
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Ischemia focused on measuring Blood Pressure, Atherosclerosis, Brain Ischemia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chungnam National University Hospital
  • Myongji Hospital
  • Wonkwang University Hospital
  • Inje University Pusan Paik Hospital
  • Yeungnam University Hospital
  • Eulji University Hospital
  • Kyungpook National University Hospital
  • Chonnam National University Hospital
  • Inha University Hospital
  • Dong-A University Hospital
  • Kyung Hee University Medical Center
  • Seoul Medical Center
  • Korea University Anam Hospital
  • Asan Medical Center
  • Eulji Hospital
  • Boramae Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aggressive BP lowering

Modest BP lowering

Arm Description

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

Lowering of systolic blood pressure between 130mmHg and 140mmHg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
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
Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
Number of Participants With Adverse Events
Number of Participants with Adverse Events

Full Information

First Posted
April 14, 2010
Last Updated
January 17, 2017
Sponsor
Asan Medical Center
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01104311
Brief Title
Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis
Acronym
STABLE-ICAS
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
The enrollment was not done actively even though enrollment period was extended due to poor enrollment.
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia
Keywords
Blood Pressure, Atherosclerosis, Brain Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aggressive BP lowering
Arm Type
Experimental
Arm Description
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Arm Title
Modest BP lowering
Arm Type
Active Comparator
Arm Description
Lowering of systolic blood pressure between 130mmHg and 140mmHg
Intervention Type
Procedure
Intervention Name(s)
Aggressive BP lowering
Other Intervention Name(s)
Aggressive BP control
Intervention Description
adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
Intervention Type
Procedure
Intervention Name(s)
modest blood pressure lowering
Other Intervention Name(s)
Modest BP control
Intervention Description
adjust the amount and number of antihypertensive drugs
Primary Outcome Measure Information:
Title
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)
Description
The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Time Frame
Screening to 24 weeks
Secondary Outcome Measure Information:
Title
Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
Description
the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI
Time Frame
24 weeks
Title
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
Time Frame
24 weeks
Title
Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
Time Frame
24 weeks
Title
Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
Time Frame
24 Week
Title
Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
Time Frame
24 Weeks
Title
Number of Participants With Adverse Events
Description
Number of Participants with Adverse Events
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Chungnam
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
412-270
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Jeonbuk
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Deagu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inchon
ZIP/Postal Code
400-103
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Pusan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
ZIP/Postal Code
135-740
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Eulji Hospital
City
Seoul
ZIP/Postal Code
139-872
Country
Korea, Republic of
Facility Name
Boramae Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no plan to share data yet. It will be discussed with investigators who have been participating in this study.
Citations:
PubMed Identifier
29847486
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.
Results Reference
derived

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

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