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

January 17, 2017 updated by: Sun U. Kwon, Asan Medical Center

Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Inje University Pusan Paik Hospital
      • Daegu, Korea, Republic of, 705-717
        • Yeungnam University Hospital
      • Daejon, Korea, Republic of, 302-799
        • Eulji University Hospital
      • Deagu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Inchon, Korea, Republic of, 400-103
        • Inha University Hospital
      • Pusan, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 156-707
        • Boramae Hospital
      • Seoul, Korea, Republic of, 135-740
        • Seoul Medical Center
      • Seoul, Korea, Republic of, 130-702
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of, 139-872
        • Eulji Hospital
    • Chungnam
      • Daejeon, Chungnam, Korea, Republic of, 301-721
        • Chungnam National University Hospital
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 412-270
        • Myongji Hospital
    • Jeonbuk
      • Iksan, Jeonbuk, Korea, Republic of, 570-711
        • Wonkwang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aggressive BP lowering
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
Procedure: Aggressive BP lowering
adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
Other Names:
  • Aggressive BP control
Active Comparator: Modest BP lowering
Lowering of systolic blood pressure between 130mmHg and 140mmHg
Procedure: modest blood pressure lowering
adjust the amount and number of antihypertensive drugs
Other Names:
  • Modest BP control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Screening to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
Time Frame: 24 weeks
24 weeks
Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
Time Frame: 24 weeks
24 weeks
Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
Time Frame: 24 Week
24 Week
Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
Time Frame: 24 Weeks
24 Weeks
Number of Participants With Adverse Events
Time Frame: 24 Weeks
Number of Participants with Adverse Events
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STABLE-ICAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is no plan to share data yet. It will be discussed with investigators who have been participating in this study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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