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

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ClinicalTrials.gov Identifier: NCT01104311
Recruitment Status : Terminated (The enrollment was not done actively even though enrollment period was extended due to poor enrollment.)
First Posted : April 15, 2010
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sun U. Kwon, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE April 14, 2010
First Posted Date  ICMJE April 15, 2010
Results First Submitted Date  ICMJE February 11, 2016
Results First Posted Date  ICMJE March 7, 2017
Last Update Posted Date March 7, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) [ Time Frame: Screening to 24 weeks ]
The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) [ Time Frame: 24 weeks ]
The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Change History Complete list of historical versions of study NCT01104311 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population [ Time Frame: 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 [ Time Frame: 24 weeks ]
  • Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population. [ Time Frame: 24 weeks ]
  • Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population. [ Time Frame: 24 Week ]
  • Number of Participants With Vascular Death From Screening to Week 24 in ITT Population. [ Time Frame: 24 Weeks ]
  • Number of Participants With Adverse Events [ Time Frame: 24 Weeks ]
    Number of Participants with Adverse Events
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
  • Ischemic lesion volume change in the territory of symptomatic intracranial disease on FLAIR MRI [ Time Frame: 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 [ Time Frame: 24 weeks ]
  • The number of cardiovascular event [ Time Frame: 24 Week ]
  • The number of vascular death [ Time Frame: 24 Weeks ]
  • The number of adverse event [ Time Frame: 24 Weeks ]
  • The number of adverse drug reaction [ Time Frame: 24 weeks ]
  • The number of adverse drug reaction related to experimental drug [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis
Official Title  ICMJE Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Ischemia
Intervention  ICMJE
  • Procedure: Aggressive BP lowering
    adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
    Other Name: Aggressive BP control
  • Procedure: modest blood pressure lowering
    adjust the amount and number of antihypertensive drugs
    Other Name: Modest BP control
Study Arms  ICMJE
  • Experimental: Aggressive BP lowering
    Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
    Intervention: Procedure: Aggressive BP lowering
  • Active Comparator: Modest BP lowering
    Lowering of systolic blood pressure between 130mmHg and 140mmHg
    Intervention: Procedure: modest blood pressure lowering
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 17, 2017)
132
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2010)
156
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01104311
Other Study ID Numbers  ICMJE STABLE-ICAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: There is no plan to share data yet. It will be discussed with investigators who have been participating in this study.
Responsible Party Sun U. Kwon, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Asan Medical Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP