Overview

This trial is active, not recruiting.

Condition brain ischemia
Treatments aggressive bp lowering, modest blood pressure lowering
Phase phase 4
Sponsor Asan Medical Center
Collaborator Pfizer
Start date April 2010
End date April 2014
Trial size 156 participants
Trial identifier NCT01104311, STABLE-ICAS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period
aggressive bp lowering Aggressive BP control
adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
(Active Comparator)
Lowering of systolic blood pressure between 130mmHg and 140mmHg
modest blood pressure lowering Modest BP control
adjust the amount and number of antihypertensive drugs

Primary Outcomes

Measure
Ischemic lesion volume change in the whole forebrain on fluid attenuation inversion recovery (FLAIR) magnetic resonance imaging (MRI)
time frame: 24 weeks

Secondary Outcomes

Measure
Ischemic lesion volume change in the territory of symptomatic intracranial disease on FLAIR MRI
time frame: 24 weeks
The number of patients with new ischemic lesion in the whole forebrain on FLAIR MRI
time frame: 24 weeks
The number of cardiovascular event
time frame: 24 weeks
The number of vascular death
time frame: 24 weeks
The number of adverse event
time frame: 24 weeks
The number of adverse drug reaction
time frame: 24 weeks
The number of adverse drug reaction related to experimental drug
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Asan Medical Center.