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Acute Candesartan Cilexetil Outcomes Stroke Trial (ACCOST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by City Hospitals Sunderland NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00108706
First Posted: April 19, 2005
Last Update Posted: September 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by:
City Hospitals Sunderland NHS Foundation Trust
  Purpose
The aim of this study is to determine whether it is safe and effective to give the Angiotensin Receptor Blocker (ARB) Candesartan within the first 72 hours following acute stroke.

Condition Intervention Phase
Cerebrovascular Accident Acute Stroke Drug: Candesartan Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Acute Candesartan Cilexetil Outcomes Stroke Trial (ACCOST)

Resource links provided by NLM:


Further study details as provided by City Hospitals Sunderland NHS Foundation Trust:

Primary Outcome Measures:
  • Mortality (all causes)
  • Mortality (vascular causes)

Secondary Outcome Measures:
  • Neurological Recovery (NIHSS [National Institutes of Health Stroke Scale])
  • Functional Recovery (Modified Rankin/Barthel)

Estimated Enrollment: 50
Study Start Date: December 2004
Estimated Study Completion Date: September 2007
Detailed Description:

Lowering blood pressure reduces the risk of first ever and recurrent stroke. There is extensive evidence that blood pressure should be lowered following acute stroke, even from so called normal levels. However, it is not clear how soon after acute stroke that blood pressure should be lowered. Observational studies have demonstrated increased mortality with both high and low blood pressure. The optimal management of blood pressure in the immediate post-stroke period remains controversial.

Although uncertainty exists with regard to lowering blood pressure in the acute stages of stroke, two large randomised controlled trials have demonstrated unequivocally that intense management of blood pressure started >4 weeks from the onset of stroke significantly reduces the risk of recurrent stroke. Both of these trials have used an Angiotensin Converting Enzyme Inhibitor (ACE-I) based regime. It has been proposed that these benefits may be due to a direct result of the ACE-I rather than blood pressure lowering per se. Similar vasculoprotective effects have been seen in ARBs, but evidence of their safety and efficacy in acute stroke is limited to those patients with the highest blood pressures (>200/110). The trial (ACCESS) was terminated prematurely due to a positive imbalance in favour of intervention with the ARB Candesartan. If such interventions are to convey potential benefit they need to be started as soon as possible following the acute event in order that the ischaemic cascade which leads to neuronal death may be modified. Further research is first required in order to demonstrate their safety and efficacy when used in this way.

ACCOST is a two phase randomised controlled trial designed to address this important research question. Phase I is a four week double blind placebo controlled phase where patients receive either Candesartan 4 mg daily or matched placebo, with no blood pressure treatment target. A treatment titration step occurs after two weeks where, subject to titration criteria, subjects will receive either Candesartan 8 mg daily or matched placebo. After the first four weeks, the subjects are unblinded and enter Phase II of the trial. Phase II is an eight week open label comparison of Candesartan and 'usual care' with an ACE-I based treatment regime. Blood pressure is now treated to reach the British Hypertension Society target blood pressure of <140/85, with or without additional therapy.

Blinded outcome measures will include neurological recovery based on the National Institutes of Health Stroke Scale, as well as functional recovery. Incidence of first dose hypotension and changes in renal function will also be collected.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute ischaemic stroke <72 hours from symptom onset (CT proven)
  • Medically stable with no evidence of acute infection and not receiving antibiotic therapy
  • Neurologically stable (no progression on NIHSS)
  • Able to swallow unthickened fluids safely
  • Mean BP (blood pressure) >120/70 in unaffected arm

Exclusion Criteria:

  • Previous severe disability (Modified Rankin Score >2)
  • Nursing home residents
  • Previous history of congestive heart failure requiring treatment with ACE-Inhibitors or angiotensin receptor blockers
  • Renal impairment (creatinine >200 mcgmol/L)
  • Women of child bearing potential
  • Minors <18 years of age
  • History of dementia without ability to consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108706


Locations
United Kingdom
Sunderland Royal Hospital
Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
Sponsors and Collaborators
City Hospitals Sunderland NHS Foundation Trust
Takeda
Investigators
Principal Investigator: Christopher S Gray, MD University of Newcastle Upon-Tyne
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00108706     History of Changes
Other Study ID Numbers: ACCOST
CTA Number:21763/0001/001
EudraCT Number:2004-001847-31
First Submitted: April 18, 2005
First Posted: April 19, 2005
Last Update Posted: September 13, 2006
Last Verified: September 2006

Keywords provided by City Hospitals Sunderland NHS Foundation Trust:
Acute Stroke
Cerebrovascular Accident
Ischaemic Stroke
Candesartan
Angiotensin Receptor Blocker

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action