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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sun U. Kwon, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01104311
First received: April 14, 2010
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Brain Ischemia
Procedure: Aggressive BP lowering
Procedure: modest blood pressure lowering
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Ischemic lesion volume change in the whole forebrain on fluid attenuation inversion recovery (FLAIR) magnetic resonance imaging (MRI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    the difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI


Secondary Outcome Measures:
  • Ischemic lesion volume change in the territory of symptomatic intracranial disease on FLAIR MRI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • The number of cardiovascular event [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The number of vascular death [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The number of adverse event [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The number of adverse drug reaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The number of adverse drug reaction related to experimental drug [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Modest BP control

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute symptomatic ischemic stroke having relevant lesion on DWI MRI 7 days after and 42 days within onset.
  • relevant stenosis(more than 50%) or occlusion from MCA(M1) to distal of ICA on MR 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, 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104311

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

No publications provided

Responsible Party: Sun U. Kwon, department of neurology, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01104311     History of Changes
Other Study ID Numbers: STABLE-ICAS
Study First Received: April 14, 2010
Last Updated: October 8, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Blood Pressure
Atherosclerosis
Brain Ischemia

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Brain Ischemia
Intracranial Arteriosclerosis
Brain Diseases
Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014