Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120003
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-07-06
Brief Title:
Scandinavian Candesartan Acute Stroke Trial SCAST
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Scandinavian Candesartan Acute Stroke Trial
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to assess whether the blood pressure lowering agent candesartan an angiotensin receptor type 1 blocker is effective when given to patients with acute stroke and elevated blood pressure
Hypothesis
AT1 receptor blockade with candesartan in acute stroke will
1 reduce the risk of death or major disability at 6 months by a 6 absolute risk reduction relative to placebo
2 reduce the risk of the combined event of vascular death myocardial infarction or stroke during the first 6 months by a 25 relative risk reduction relative to placebo
Hypothesis
AT1 receptor blockade with candesartan in acute stroke will
1 reduce the risk of death or major disability at 6 months by a 6 absolute risk reduction relative to placebo
2 reduce the risk of the combined event of vascular death myocardial infarction or stroke during the first 6 months by a 25 relative risk reduction relative to placebo
Detailed Description:
It has long been a controversy whether elevated blood pressure should be lowered in the acute phase of stroke Current clinical practice is generally to accept high blood pressure in the acute phase of stroke to avoid reduction of cerebral blood perfusion This practice has a well-founded theoretical basis but is not supported by evidence from clinical trials The newly published study ACCESS Stroke 2003341699 showed a clear beneficial effect of the angiotensin receptor blocker candesartan in the acute phase of stroke but the trial was seriously underpowered
The Scandinavian Candesartan Acute Stroke Trial SCAST is designed to provide reliable data on the effects of candesartan in a wide variety of patients with acute stroke target recruitment 2500 Patients presenting with acute stroke 30 hours and systolic blood pressure 140 mm Hg will be randomly assigned to candesartan 4 to 16 mg once daily or matching placebo for 7 days followed by candesartan treatment for 6 months for patients who are hypertensive at the end of the treatment period at clinicians discretion Follow-up will be performed double-blind at 30 days 3 months and 6 months
The trial is co-ordinated from Ullevaal University Hospital in Oslo Norway Over 100 centres from Norway Sweden Denmark and Belgium have agreed to participate Financial contributors The Eastern Norway Regional Health Authority AstraZeneca and Ullevaal University Hospital Oslo AstraZeneca will supply drugs and placebo for the trial
The Scandinavian Candesartan Acute Stroke Trial SCAST is designed to provide reliable data on the effects of candesartan in a wide variety of patients with acute stroke target recruitment 2500 Patients presenting with acute stroke 30 hours and systolic blood pressure 140 mm Hg will be randomly assigned to candesartan 4 to 16 mg once daily or matching placebo for 7 days followed by candesartan treatment for 6 months for patients who are hypertensive at the end of the treatment period at clinicians discretion Follow-up will be performed double-blind at 30 days 3 months and 6 months
The trial is co-ordinated from Ullevaal University Hospital in Oslo Norway Over 100 centres from Norway Sweden Denmark and Belgium have agreed to participate Financial contributors The Eastern Norway Regional Health Authority AstraZeneca and Ullevaal University Hospital Oslo AstraZeneca will supply drugs and placebo for the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None