Antihypertensive Treatment in Acute Cerebral Hemorrhage-II (ATACH-II)

Description:

The purpose of this trial is to determine the effectiveness of early, intensive antihyperintensive treatment using intravenous nicardipine in people with hypertension and intracerebral hemorrhage (ICH).  Nicardipine is an antihypertensive medication.

An estimated 37,000 to 52,400 people in the United States have ICH every year.  ICH is a form of stroke that has poor outcome and is difficult to treat.  It is associated with the highest mortality rate of all strokes.  Hematoma expansion has been identified as the most common cause of neurological deterioration in people with ICH.  Early evidence suggests that acute hypertension (HTN), or elevated blood pressure, may make some individuals more susceptible to hematoma expansion.  Treating HTN may prevent hematoma expansion, however, the effect of aggressive HTN treatment has not been determined.

This 5-year, international, multi-center trial—which will enroll 1280 individuals— is the natural extension of numerous case series, a subsequent pilot trial (ATACH-I), and a preliminary randomized controlled trial (INTERACT-I).  The purpose is to evaluate the efficacy and safety of using nicardipine to lower blood pressure in people who have acute HTN associated with ICH.

Phase: 

Eligibility Criteria:

Inclusion:

• Age 18 years or older.
• Intravenous nicardipine can be initiated within 4.5 hours of symptom onset.
• Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
• Total Glasgow Coma Scale score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department arrival.
• International normalized ratio value < 1.5.
• Computed tomography (CT) scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc.
• For subjects randomized prior to IV antihypertensive administration:  Systolic blood pressure (SBP) greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) and without spontaneous SBP reduction to below 180 mmHg at the time of randomization, or
• For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) and without SBP reduction to below 140 mmHg at the time of randomization.

  *Note: Patients with SBP < 180mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.

Exclusion:

• ICH is due to previously known neoplasms, arteriovenous malformation, or aneurysms.
• Intracerebral hematoma considered to be related to trauma.
• ICH located in infratentorial regions such as pons or cerebellum.
• Intraventricular hemorrhage associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles.
• Patient to receive immediate surgical evacuation.
• Current pregnancy, or parturition within previous 30 days, or active lactation.
• Use of dabigatran within the last 48 hours.
• A platelet count less than 50,000/mm3.
• Known sensitivity to nicardipine.
• Pre-morbid disability requiring assistance in ambulation or activities of daily living.
• Subject's living will precludes aggressive intensive care unit management.
• Subject is currently participating in another interventional clinical trial.

Study Design: 

Study Locations: 

For more information:

Contact:  Adnan I Qureshi, MD; telephone: 612-625-1969; email: qureshi@umn.edu;

Visit:  http://clinicaltrials.gov/ct2/show/NCT01176565

Last Reviewed December 17, 2012