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

NCT01104311 | Terminated Phase 4 Results

• 1 other identifier: STABLE-ICAS
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 16

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.

Conditions

Brain Ischemia

Keywords

Blood Pressure; Atherosclerosis; Brain Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

  Screening to 24 weeks

Secondary Outcomes (6)

• Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population

  24 weeks

• The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI

  24 weeks

• Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.

  24 weeks

• Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.

  24 Week

• Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.

  24 Weeks

Study Arms (2)

Aggressive BP lowering

EXPERIMENTAL

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

Procedure: Aggressive BP lowering

Modest BP lowering

ACTIVE COMPARATOR

Lowering of systolic blood pressure between 130mmHg and 140mmHg

Procedure: modest blood pressure lowering

Interventions

Aggressive BP lowering PROCEDURE

adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level

Also known as: Aggressive BP control

Aggressive BP lowering

modest blood pressure lowering PROCEDURE

adjust the amount and number of antihypertensive drugs

Also known as: Modest BP control

Modest BP lowering

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Pfizer: collaborator

Study Sites (16)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, 301-721, South Korea

Location

Myongji Hospital

Goyang-si, Gyeonggi-do, 412-270, South Korea

Location

Wonkwang University Hospital

Iksan, Jeollabuk-do, 570-711, South Korea

Location

Inje University Pusan Paik Hospital

Busan, 614-735, South Korea

Location

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Eulji University Hospital

Daejeon, 302-799, South Korea

Location

Kyungpook National University Hospital

Deagu, 700-721, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Inha University Hospital

Inchon, 400-103, South Korea

Location

Dong-A University Hospital

Pusan, 602-715, South Korea

Location

Kyung Hee University Medical Center

Seoul, 130-702, South Korea

Location

Seoul Medical Center

Seoul, 135-740, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Eulji Hospital

Seoul, 139-872, South Korea

Location

Boramae Hospital

Seoul, 156-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29847486 DERIVED

MeSH Terms

Conditions

Brain Ischemia; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Sun U. Kwon, MD, PhD, Prof
• Organization: Asan Medical Center, University of Ulsan

sukwon@amc.seoul.kr

82-2-3010-3960

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of neurology

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 7, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-01

Locations

KR (16)