Controlling Hypertension After Severe Cerebrovascular Event "CHASE"

Not yet recruiting

Phase N/A Results N/A

Trial Description

The purpose of this academic lead study is to explore ideal blood pressure targets and optimum individualized anti-hypertension strategies in acute severe stroke.

Detailed Description

Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on blood pressure (BP) management. Unfortunately, so far no ideal BP range has been scientifically determined for patients with acute severe stroke.
The CHASE study aims to provide reliable data on the effects of individualized anti-hypertension strategy in patients with acute severe stroke (target recruitment 250) compared to standard guideline-based management of BP (target recruitment 250). Patients presenting with acute (<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and elevated BP (systolic blood pressure ≧150 mmHg or diastolic blood pressure ≧ 100 mmHg) will be randomly assigned to individualized anti-hypertension treatment or guideline-based treatment for 7 days.

Conditions

Interventions

  • Blood pressure management policies Other
    Other Names: Labetalol Hydrochloride; Metoprolol tartrate; Hydralazine Hydrochloride; Glycerol Trinitrate; Phentolamine mesylate; Nicardipine; Urapidil; Esmolol; Clonidine; Enalaprilat; nitroprusside
    ARM 1: Kind: Experimental
    Label: Individualized BP lowering
    Description: Management policy is to lower the systolic or diastolic BP by 10-15% within 24 hours of randomization and sustained for 7 days. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
    ARM 2: Kind: Experimental
    Label: Guideline recommended BP lowering
    Description: Patients received management of BP based on the standard guidelines at the time, as published by the Chinese Society of Neurology (CSN) in 2014. The attending clinician may consider commencing BP treatment and sustained for 7 days if the systolic BP > 200 mmHg or diastolic BP >110 mmHg in patients with ischemic stroke, and systolic BP > 180 mmHg or diastolic BP > 110 mmHg in patients with cerebral hemorrhage.

Outcomes

Type Measure Time Frame Safety Issue
Primary Death or major disability (defined by the modified Rankin scale) 3 months after onset
Secondary National Institute of Health stroke scale 14 days after onset
Secondary Symptomatic hypotension 7 days
Secondary Renal failure 7 days
Secondary Blood coagulation disorder 7 days
Secondary Adverse Events That Are Related to Treatment 7 days

Sponsors