Antihypertensive Treatment in Acute Cerebral Hemorrhage

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00415610
• Date of registration: 21/12/2006
• Primary sponsor: University of Minnesota - Clinical and Translational Science Institute
• Public title: Antihypertensive Treatment in Acute Cerebral Hemorrhage ATACH
• Scientific title: Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH)
• Date of first enrolment: July 2005
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00415610
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Adnan I. Qureshi, MD
• Affiliation: University of Minnesota - Clinical and Translational Science Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age older than 18 years.

- Onset of new neurological signs of a stroke within 12 hours of the time to evaluation
AND initiation of treatment with intravenous nicardipine.

- Clinical signs consistent with the diagnosis of stroke, including impairment of
language, motor function, cognition, and/or gaze, vision, or neglect.

- The total GCS score is greater than 8 at the time of enrollment.

- CT scan demonstrates intraparenchymal hematoma with manual hematoma volume
measurement less than 60 cc.

- ICH is supratentorial and is located in lobar, basal ganglionic, or thalamic based on
the initial CT scan appearance.

- Admission systolic blood pressure greater than 170 mm Hg on two repeat measurements
at least 5 minutes apart.

- Evidence of chronic hypertension.

- Subject is not considered a surgical candidate by the neurosurgery service.

Exclusion Criteria:

- Time of symptom onset cannot be reliably assessed.

- Previously known neoplasms, arteriovenous malformation, or aneurysms.

- Intracerebral hematoma considered to be related to trauma by the neurologist or
neurosurgeon.

- ICH is located in the cortex or infratentorial regions such as pons or cerebellum.

- Blood is visualized in the subarachnoid space.

- Intravenous nicardipine cannot be initiated within 12 hours of symptom onset.

- Use of clonidine hydrochloride and other central alpha-agonist within the last 48
hours that have the potential of withdrawal hypertension.

- Pregnancy, lactation, or parturition within previous 30 days.

- Any history of bleeding diathesis or coagulopathy, including the use of warfarin.

- Use of heparin in the previous 48 hours and a prolonged partial thromboplastin time.

- Known atrial-ventricular heart block other than first degree, or sick sinus syndrome
without a pacemaker.

- Intolerance to calcium channel blockers.

- Exposure to study medication in the preceding 24 hours prior to enrollment.

- A platelet counts less than 100 000/mm3.

- Major surgery within the previous six weeks.

- History of any intracranial hemorrhage (including intracerebral or subarachnoid
hemorrhage) or hemorrhagic stroke.

- Seizure at onset of stroke.

- Blood glucose less than 50 mg/dL or greater than 400 mg/dL.

- Current participation in another research drug treatment protocol.

- Isolated ventricular blood on CT scan.

- Subject has a living will that precludes aggressive intensive care unit management.

- Subject has acute myocardial infarction or renal failure that precludes use of
aggressive antihypertensive therapy.

- Subjects with unstable angina or acute myocardial infarction within 2 weeks prior to
ICH.

- Subjects with renal insufficiency with serum creatinine greater than 2.0 mg/dl or on
renal dialysis.

- Sinus tachycardia exceeding 120 beats per minute or supraventricular tachycardia is
observed during initial evaluation.

- Ischemic stroke within 4 weeks of presentation.

- Congestive heart failure graded as class III and IV by New York Heart Association
(NYHA) classification.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intracerebral Hemorrhage

Stroke

Intervention(s)

Drug: nicardipine

Primary Outcome(s)

Tolerability, the ability to achieve reduction of blood pressure and maintain treatment goals (the specified systolic blood pressure range for the 18-24 hour period) without neurological deterioration or side effects [Time Frame: 18-24 hour period]

Secondary Outcome(s)

Safety, as determined by the amount of neurological deteriorations during the 24 hour treatment period, plus the number of serious adverse events [Time Frame: within the first 72 hours of treatment initiation]

Secondary ID(s)

0609M93128

R01NS44976-01A2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)