Antihypertensive treatments for spontaneous intracerebral hemorrhage in patients with cerebrovascular stenosis: A randomized clinical trial (ATICHST)

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Abstract

Introduction:

Antihypertensive treatment is associated with clinical outcomes in patients with spontaneous intracerebral hemorrhage (sICH). ADAPT showed that intensive blood pressure lowering (<140 mm Hg) does not reduce peri-hematoma regional cerebral blood flow (rCBF) in patients with sICH. However, the stenosis of main cerebral arteries that has a high presence in patients with sICH is well-known related to the brain ischemia. The effect of intensive BP lowering for sICH in patients with cerebrovascular stenosis is still unknown.

Aim:

The aim of this study was to determine the safety and effectiveness of intensive BP lowering for sICH in patients with cerebrovascular stenosis.

Methods and analysis:

A pilot trial has been conducted to calculate the sample size and 80 patients of sICH with cerebrovascular stenosis will be involved. The target of systolic blood pressure (SBP) will be maintained at from 120 to 140 mm Hg or from 140 to 180 mm Hg for 7 days. Cerebral ischemia will be assessed at 24 hours after onset by computed tomography (CT) perfusion imaging and the follow-up will be conducted at 30-day and 90-day. The primary outcome is the reduction of peri-hematoma rCBF. The other cerebral perfusion indexes and the rate of ischemic stroke are regarded as other primary outcomes. The secondary outcomes include clinical outcome at 30 days and 90 days, complications, and hospital stays.

Discussion:

The ATICHST trial has been signed as a parallel, prospective, randomized, assessor-blinded clinical trial to determine the effects of intensive BP lowering on sICH in patients with cerebrovascular stenosis, the results of which will contribute to guide the management of blood pressure in sICH.

Conclusion:

The protocol will determine the safety and effectiveness of intensive BP lowering for sICH with cerebrovascular stenosis.

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