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Clinical Trials/EUCTR2015-001953-33-GB
EUCTR2015-001953-33-GB
Active, not recruiting
Phase 1

Preventing cognitive decline and dementia from cerebral small vessel disease - Prevent-SVD

niversity of Edinburgh0 sites60 target enrollmentAugust 27, 2015
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Conditionsacunar (small vessel) ischaemic strokeMedDRA version: 19.0 Level: LLT Classification code 10023987 Term: Late effects of cerebrovascular disease System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10068644 Term: Brain stem stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10071043 Term: Basal ganglia stroke System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsIsotard 25 mg XLCilostazol 50 mg tabletsPletal 50 mg tablets

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
acunar (small vessel) ischaemic stroke
Sponsor
niversity of Edinburgh
Enrollment
60
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 27, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity of Edinburgh

Eligibility Criteria

Inclusion Criteria

  • •Mild symptomatic ischaemic stroke in the past four years compatible with a 1\. Clinical lacunar stroke syndrome, with brain MRI or CT scanning that is compatible with a symptomatic small subcortical (lacunar) infarct, or if no recent relevant infarct is visible, that excluded other cause for symptoms
  • •2\. Age \> 35 years
  • •3\. Independent in activities of daily living (modified Rankin \=2\)
  • •4\. Able to give consent themselves
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 30

Exclusion Criteria

  • •Other significant active neurological illness present since suffering stroke
  • •(e.g. seizures, multiple sclerosis, brain tumour)
  • •Montreal Cognitive Assessment score \<20
  • •Requiring assistance with activities of daily living (Modified Rankin \=3\)
  • •Active cardiac disease (atrial fibrillation, myocardial infarction in past 6
  • •months, active angina, symptomatic cardiac failure)
  • •Carotid stenosis \> 50% NASCET in the symptomatic artery territory requiring
  • •carotid endarterectomy (prior and apparently successful carotid
  • •endarterectomy is not an exclusion criterion)
  • •Definite indication for (i.e. already prescribed either trial medication),

Outcomes

Primary Outcomes

Not specified

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