Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial (ICH ADAPT)

This study has been completed.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Alberta Heritage Foundation for Medical Research
Information provided by (Responsible Party):
Ken Butcher, University of Alberta
ClinicalTrials.gov Identifier:
NCT00963976
First received: August 21, 2009
Last updated: February 24, 2012
Last verified: February 2012
  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 2

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:


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 ]

Enrollment: 74
Study Start Date: January 2007
Study Completion Date: February 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada, T6G2B7
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada
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):
Responsible Party: Ken Butcher, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00963976     History of Changes
Other Study ID Numbers: ICHADAPT513000128
Study First Received: August 21, 2009
Last Updated: February 24, 2012
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
Enalapril
Hydralazine
Labetalol
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014