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Clinical Trials/ISRCTN85562386
ISRCTN85562386
Completed
Phase 4

Prevention Of Decline in Cognition After Stroke Trial (PODCAST): a factorial randomised controlled trial of intensive versus guideline (moderate) lowering of blood pressure and lipids

The University of Nottingham (UK)0 sites3,400 target enrollmentSeptember 23, 2009
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ConditionsCognitive impairment after strokeMental and Behavioural DisordersOther mental disorders due to brain damage and dysfunction and to physical disease

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Cognitive impairment after stroke
Sponsor
The University of Nottingham (UK)
Enrollment
3400
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 23, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The University of Nottingham (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Age greater than 70 years and telephone\-administered mini\-mental state examination (MMSE) greater than 16; or aged greater than 60 years and telephone\-MMSE 17 \- 19, either sex
  • •2\. Functionally independent (modified Rankin Scale \[mRS] 0 \- 2\)
  • •3\. Ischaemic stroke (any cortical Oxfordshire Community Stroke Project \[OCSP]/Trial of ORG 10172 in Acute Stroke Treatment \[TOAST] type) or primary intracerebral haemorrhage (cortical or basal ganglia)
  • •4\. Three to seven months post\-event (to allow cognitive, neurological, blood pressure \[BP] and lipid stabilisation, but avoid attrition)
  • •5\. Systolic BP 125 \- 170 mmHg
  • •6\. Total cholesterol 3 \- 8 mmol/l
  • •7\. Presence of a reporter: partner, sibling, child, friend (for Informant Questionnaire of Cognitive Decline \[IQCODE]/Dementia Quality of Life \[DEMQoL])
  • •8\. Capacity and willingness to give consent

Exclusion Criteria

  • •1\. Participants not meeting inclusion criteria
  • •2\. Subarachnoid haemorrhage
  • •3\. Secondary intracranial haemorrhage (trauma, arteriovenous malformation \[AVM], cavernoma)
  • •4\. Posterior circulation ischaemic stroke
  • •5\. Posterior circulation haemorrhage
  • •6\. No computed tomography (CT)/magnetic resonance imaging (MRI) during index stroke
  • •7\. Inability to give consent or do study measures, e.g. severe dysphasia, weakness of dominant arm
  • •8\. Severe hypertension (systolic BP greater than 170 mmHg)
  • •9\. Definite need for 'intensive' BP control
  • •10\. Severe hypercholesterolemia (total cholesterol \[TC] greater than 8 mmol/l)

Outcomes

Primary Outcomes

Not specified

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