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

Active, not recruiting

Phase 4 Results N/A

Update History

11 Oct '14
The Summary of Purpose was updated.
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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.
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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 below 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP below 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis
The eligibility criteria were updated.
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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.
Old
Inclusion Criteria: - acute symptomatic ischemic stroke having relevant lesion on DWI MRI 7 days after and 28 days within onset. - relevant significant stenosis(more than 50%) or occlusion of MCA(M1) or 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
A location was updated in Daejeon.
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The overall status was removed for Chungnam National University Hospital.
A location was updated in Iksan.
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The overall status was removed for Wonkwang University Hospital.
A location was updated in Busan.
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The overall status was removed for Inje University Pusan Paik Hospital.
A location was updated in Daegu.
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The overall status was removed for Yeungnam University Hospital.
A location was updated in Daejon.
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The overall status was removed for Eulji University Hospital.
A location was updated in Deagu.
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The overall status was removed for Kyungpook National University Hospital.
A location was updated in Gwangju.
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The overall status was removed for Chonnam National University Hospital.
A location was updated in Inchon.
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The overall status was removed for Inha University Hospital.
A location was updated in Pusan.
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The overall status was removed for Dong-A University Hospital.
A location was updated in Seoul.
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The overall status was removed for Seoul Medical Center.
A location was updated in Seoul.
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The overall status was removed for Kyung Hee University Medical Center.
A location was updated in Seoul.
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The overall status was removed for Eulji Hospital.
A location was updated in Seoul.
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The overall status was removed for Asan Medical Center.
A location was updated in Seoul.
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The overall status was removed for Boramae Hospital.
16 Jun '12
A location was updated in Daejeon.
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The overall status was removed for Chungnam National University Hospital.
A location was updated in Wonju.
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The overall status was updated to "Withdrawn" at Wonju Christian Hospital.
27 Jan '12
A location was updated in Suwon.
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The overall status was updated to "Terminated" at Ajou University Hospital.
A location was updated in Seoul.
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The overall status was updated to "Terminated" at Seoul National University Hospital.