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| Sponsor: | University of Alberta |
|---|---|
| Collaborators: |
Heart and Stroke Foundation of Ontario 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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial |
| Estimated Enrollment: | 74 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Target systolic BP < 150 mmHg: Experimental
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).
|
|
Target systolic BP < 180 mmHg: Active Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ken S Butcher, MD, PhD, FRCPC | 780 407 2171 | ken.butcher@ualberta.ca |
| Canada, Alberta | |
| 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 | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Andrew Demchuk, MD, FRCPC 403 944 8671 ademchuk@ucalgary.ca | |
| Principal Investigator: Andrew Demchuk, MD, FRCPC | |
| Canada, Ontario | |
| University of Ottawa | Not yet recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Dar Dowlatshahi, MD PhD FRCPC 613 737 8899 ext 16449 dowlatd@yahoo.com | |
| Principal Investigator: Dar Dowlatshahi, MD PhD FRCPC | |
More Information
| Responsible Party: | University of Alberta ( Dr Ken Butcher ) |
| Study ID Numbers: | ICHADAPT513000128 |
| Study First Received: | August 21, 2009 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00963976 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Stroke Hypertension Cerebral Blood Flow CT Perfusion |
|
Vasodilator Agents Cerebral Hemorrhage Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Hydralazine Physiological Effects of Drugs Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Labetalol Enalapril Pathologic Processes Therapeutic Uses |
Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Cardiovascular Diseases Sympatholytics Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Autonomic Agents Adrenergic Antagonists |
