Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial - Full Text View

Sponsor:	University of Alberta
Collaborators:	Heart and Stroke Foundation of Canada Alberta Heritage Foundation for Medical Research
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00963976

Purpose

Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage (ICH) remains controversial. Although it has been established that there is a transient moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive BP reduction.

Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of acute BP reduction to < 150 mmHg systolic using a standardized protocol in ICH patients. It is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following acute BP reduction.

Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients are randomized to a target systolic BP of < 150 mmHg or < 180 mmHg. Patients are treated with intravenous (IV) labetalol/hydralazine/enalapril.

Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma expansion rates at 24 hours.

Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any hemodynamic changes in the perihematoma region secondary to aggressive BP management. The results of this trial will facilitate ongoing and future studies aimed at determining the efficacy of rapid BP reduction in acute ICH.

Condition	Intervention	Phase
Intracerebral Hemorrhage	Drug: labetalol/hydralazine/enalapril	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Labetalol hydrochloride Labetalol Dilevalol Enalapril Enalapril maleate Enalaprilat Hydralazine Hydralazine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. [ Time Frame: 2 hours post randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hematoma expansion rates at 24 hours. [ Time Frame: 24 hours post randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	74
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Target systolic BP < 150 mmHg Systolic blood pressure will be reduced to <150 mmHg within 1 hour of randomization.	Drug: labetalol/hydralazine/enalapril Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
Active Comparator: Target systolic BP < 180 mmHg Systolic blood pressure will be reduced, to <180 mmHg within 1 hour of randomization.	Drug: labetalol/hydralazine/enalapril Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥18 years
Acute primary ICH demonstrated with CT scan
Onset ≤ 24 h prior to randomization

Exclusion Criteria:

Contraindication to BP reduction i.e., severe arterial stenosis or high-grade stenotic valvular heart disease
Indication for urgent BP reduction i.e., hypertensive encephalopathy, or aortic dissection
Definite evidence that the ICH is secondary to underlying cerebral or vascular pathology, i.e., AVM, aneurysm, tumour, trauma, vasculitis, or hemorrhagic transformation of an ischemic infarct
Previous ischemic stroke within 30 days of current event NB: Prior ICH is not an exclusion criterion
Planned surgical resection of hematoma NB: Extraventricular Drain placement is not an exclusion criterion
Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine >160 μmol/l)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963976

Contacts

Contact: Ken S Butcher, MD, PhD, FRCPC

780 407 2171

ken.butcher@ualberta.ca

Locations

Canada, Alberta
University of Calgary	Recruiting
Calgary, Alberta, Canada
Contact: Andrew Demchuk, MD, FRCPC 403 944 8671 ademchuk@ucalgary.ca
Principal Investigator: Andrew Demchuk, MD, FRCPC
University of Alberta	Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Ken S Butcher, MD PhD FRCPC 780 407 2171 ken.butcher@ualberta.ca
Principal Investigator: Ken S Butcher, MD PhD FRCPC
Grey Nuns Hospital	Not yet recruiting
Edmonton, Alberta, Canada, T6L 5X8
Contact: Brian Buck, MD 780 735 9626 bbuck@ualberta.ca
Principal Investigator: Brian Buck, MD, FRCPC
Canada, Ontario
University of Ottawa	Not yet recruiting
Ottawa, Ontario, Canada
Contact: Dar Dowlatshahi, MD PhD FRCPC 613 761 4709 dowlatd@toh.on.ca
Principal Investigator: Dar Dowlatshahi, MD PhD FRCPC

Sponsors and Collaborators

University of Alberta

Heart and Stroke Foundation of Canada

Alberta Heritage Foundation for Medical Research

More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Butcher K, Jeerakathil T, Emery D, Dowlatshahi D, Hill MD, Sharma M, Buck B, Findlay M, Lee TY, Demchuk AM. The Intracerebral Haemorrhage Acutely Decreasing Arterial Pressure Trial: ICH ADAPT. Int J Stroke. 2010 Jun;5(3):227-33.

Responsible Party:	Dr Ken Butcher, University of Alberta
ClinicalTrials.gov Identifier:	NCT00963976 History of Changes
Other Study ID Numbers:	ICHADAPT513000128
Study First Received:	August 21, 2009
Last Updated:	April 27, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Alberta:

Stroke
Hypertension
Cerebral Blood Flow
CT Perfusion

Additional relevant MeSH terms:

Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Labetalol
Enalapril
Enalaprilat
Hydralazine
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012