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

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aggressive BP lowering Procedure
    Other Names: Aggressive BP control
    Intervention Desc: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
    ARM 1: Kind: Experimental
    Label: Aggressive BP lowering
    Description: Lowering of systolic blood pressure to 120mmHg during study period
  • Modest blood pressure lowering Procedure
    Other Names: Modest BP control
    Intervention Desc: adjust the amount and number of antihypertensive drugs
    ARM 1: Kind: Experimental
    Label: Modest BP lowering
    Description: Lowering of systolic blood pressure below 140mmHg

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Ischemic lesion volume change in the whole forebrain on fluid attenuation inversion recovery (FLAIR) magnetic resonance imaging (MRI) 24 weeks No
Secondary Ischemic lesion volume change 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

Sponsors