Scandinavian Candesartan Acute Stroke Trial (SCAST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Candesartan Cilexetil Outcomes Stroke Trial (ACCOST)

NCT00108706

Cerebrovascular Accident Acute Stroke

UNKNOWN PHASE4

Evaluation of Atacand® (Candesartan) in Daily Medical Practice

NCT00837720

Hypertension

COMPLETED

Candesartan in the Prevention of Relapsing Atrial Fibrillation

NCT00130975

Atrial Fibrillation

COMPLETED PHASE3

Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)

NCT00348686

Hypertension Left Ventricular Hypertrophy

COMPLETED PHASE4

Candesartan Effect in Second Stage Arterial Hypertension

NCT00621153

Stage II Hypertension

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Candesartan Cilexetil

Group Type EXPERIMENTAL

Candesartan Cilexetil

Intervention Type DRUG

4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Candesartan Cilexetil

4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Intervention Type DRUG

Placebo

4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour)
* Systolic blood pressure ≥ 140 mm Hg
* Trial treatment possible within 30 hrs of symptom onset. If time of onset is not known, use the time when the patient was last known to be well.
* Consent (subsidiary, assent from legal acceptable representative, or waiver of consent)
* Age \>18 years

Exclusion Criteria

* Markedly reduced consciousness (i.e. Scandinavian Stroke Scale consciousness score ≤ 2)
* Patient already receiving AT1 receptor blocker
* Contraindication to treatment with AT1 receptor blocker, e.g.:

* known renal failure (women: creatinine ≥ 150 µmol/L; men: ≥ 180 µmol/L)
* previously diagnosed bilateral renal artery stenosis
* previously diagnosed high-grade aortic stenosis
* previously diagnosed seriously impaired liver function and/or cholestasis
* known intolerance to candesartan or other tablet ingredients
* Clear indication, in the clinician's view, for start of treatment with AT1 receptor blocker during the treatment period (e.g. chronic heart failure grade III-IV, in the presence of intolerance to ACE inhibitors)
* Clear indication, in the clinician's view, for antihypertensive therapy during the acute phase of stroke (i.e. concurrent hypertensive encephalopathy or aortic dissection, or other situations)
* Other serious or life-threatening disease before the stroke:
* Patient severely mentally or physically disabled (e.g. Mini Mental Status score \< 20, or modified Rankin Scale score ≥ 4)
* Life expectancy \< 12 months
* Patient unavailable for follow-up (e.g. no fixed address)
* Pregnant or breast-feeding woman

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No