NCT01104311

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Aggressive BP lowering	adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
PROCEDURE	modest blood pressure lowering	adjust the amount and number of antihypertensive drugs

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-04-01
• Completion: 2015-12-01
• First posted: 2010-04-15
• Last updated: 2017-03-07
• Results posted: 2017-03-07

Locations

16 sites across 1 country: South Korea