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

Brain Ischemia Clinical Trial

— STABLE-ICAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01104311
• Other study ID #: STABLE-ICAS
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 14, 2010
• Last updated: June 30, 2015
• Start date: April 2010
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical 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 hemisphere compared to modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: December 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Brain Ischemia
• Intracranial Arteriosclerosis

Intervention

Procedure:
• Aggressive BP lowering
adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
• modest blood pressure lowering
adjust the amount and number of antihypertensive drugs

Locations

Country	Name	City	State
Korea, Republic of	Inje University Pusan Paik Hospital	Busan
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon	Chungnam
Korea, Republic of	Eulji University Hospital	Daejon
Korea, Republic of	Kyungpook National University Hospital	Deagu
Korea, Republic of	Myongji Hospital	Goyang	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan	Jeonbuk
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Boramae Hospital	Seoul
Korea, Republic of	Eulji Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Seoul Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks	No
Secondary	Ischemic lesion volume change in the territory of symptomatic intracranial disease on FLAIR MRI	the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI	24 weeks	No
Secondary	The number of patients with new ischemic lesion in the whole forebrain on FLAIR MRI		24 weeks	No
Secondary	The number of cardiovascular event		24 weeks	No
Secondary	The number of vascular death		24 weeks	No
Secondary	The number of adverse event		24 weeks	No
Secondary	The number of adverse drug reaction		24 weeks	No
Secondary	The number of adverse drug reaction related to experimental drug		24 weeks	No