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.
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
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 2003;34:1699) 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 2,500). 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 clinician's 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.
- Candesartan cilexetil (Atacand®)Drug
Intervention Desc: 4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7 ARM 1: Kind: Experimental Label: Candesartan Cilexetil Description: Candesartan Cilexetil
- Placebo Drug
Intervention Desc: 4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7 ARM 1: Kind: Experimental Label: Placebo Description: Placebo
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Death or major disability (defined by the modified Rankin scale) at 6 months||6 months||No|
|Primary||The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months||6 months||No|
|Secondary||Scandinavian Stroke Scale score at 7 days||7 days||No|
|Secondary||Barthel Index score at 6 months||6 months||No|
|Secondary||EuroQol score at 6 months||6 months||No|
|Secondary||Mini-Mental State score at 6 months||6 months||No|
|Secondary||Death (all-cause death and "vascular" death)||6 months||No|
|Secondary||Recurrent stroke (ischaemic, haemorrhagic, or unspecified)||6 months||No|
|Secondary||Myocardial infarction||6 months||No|
|Secondary||Combination of the above events||6 months||No|
|Secondary||Symptomatic hypotension||7 days||Yes|
|Secondary||Renal failure||7 days||Yes|