Brain IschemiaPhase 4STABLE-ICASNCT01104311
Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis
A Phase 4 study testing Aggressive BP lowering and modest blood pressure lowering in people with Brain Ischemia, run by Asan Medical Center at 16 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- Aggressive BP lowering and modest blood pressure lowering
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 16 sitesSouth Korea
- Study dates
- Apr 2010to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Inje University Pusan Paik Hospital
Busan, 614-735
Yeungnam University Hospital
Daegu, 705-717
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, 301-721
Eulji University Hospital
Daejeon, 302-799
Kyungpook National University Hospital
Deagu, 700-721
Myongji Hospital
Goyang-si, Gyeonggi-do, 412-270
Chonnam National University Hospital
Gwangju, 501-757
Wonkwang University Hospital
Iksan, Jeollabuk-do, 570-711
Inha University Hospital
Inchon, 400-103
Dong-A University Hospital
Pusan, 602-715
Kyung Hee University Medical Center
Seoul, 130-702
Seoul Medical Center
Seoul, 135-740
Korea University Anam Hospital
Seoul, 136-705
Asan Medical Center
Seoul, 138-736
Eulji Hospital
Seoul, 139-872
Boramae Hospital
Seoul, 156-707
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Ischemia
- Being tested
- Aggressive BP lowering, modest blood pressure lowering
- Keywords
- Blood Pressure, Atherosclerosis, Brain Ischemia
- Medical subject headings
- Brain Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive BP loweringProcedure or surgery
Also called Aggressive BP control
adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
modest blood pressure loweringProcedure or surgery
Also called Modest BP control
adjust the amount and number of antihypertensive drugs
| Study group | Role | What they receive |
|---|---|---|
| Aggressive BP lowering | Experimental | Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Receives: Procedure: Aggressive BP lowering |
| Modest BP lowering | Active comparator | Lowering of systolic blood pressure between 130mmHg and 140mmHg Receives: Procedure: modest blood pressure lowering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI
Measured: 24 weeks
The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
Measured: 24 weeks
Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
Measured: 24 weeks
Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
Measured: 24 Week
Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
Measured: 24 Weeks
Number of Participants With Adverse Events
Number of Participants with Adverse Events
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionDec 2015
Why it stopped: The enrollment was not done actively even though enrollment period was extended due to poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Sun U. Kwon, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104311
- Sponsor's protocol ID
- STABLE-ICAS
- Acronym
- STABLE-ICAS
- Status last verified
- Jan 2017
- First submitted
- 14 Apr 2010
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: There is no plan to share data yet. It will be discussed with investigators who have been participating in this study.
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.
PubMed 29847486
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis
- ClinicalTrials.gov ID
- NCT01104311
- Acronym / sponsor ID
- STABLE-ICAS / STABLE-ICAS
- Conditions
- Brain Ischemia
- Keywords
- Blood Pressure, Atherosclerosis, Brain Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment was not done actively even though enrollment period was extended due to poor enrollment.
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive BP lowering | Experimental | Procedure: Aggressive BP loweringLowering of systolic blood pressure between 110mmHg and 120mmHg during study period |
| Modest BP lowering | Active comparator | Procedure: modest blood pressure loweringLowering of systolic blood pressure between 130mmHg and 140mmHg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive BP loweringAlso: Aggressive BP controladjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level | Procedure or surgery | Aggressive BP lowering |
| modest blood pressure loweringAlso: Modest BP controladjust the amount and number of antihypertensive drugs | Procedure or surgery | Modest BP lowering |
Primary outcome
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
6 secondary outcomes
Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
Time frame: 24 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29847486Park 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.
- Individual participant dataSharing planned: Undecided. There is no plan to share data yet. It will be discussed with investigators who have been participating in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aggressive BP lowering and modest blood pressure lowering in people with Brain Ischemia, run by Asan Medical Center at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) (time frame: Screening to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.