Preventing Cognitive Decline and Dementia from Cerebral Small Vessel Disease

Phase 1

• Conditions: acunar (small vessel) ischaemic stroke; MedDRA version: 19.0 Level: LLT Classification code 10023987 Term: Late effects of cerebrovascular disease System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0 Level: PT Classification code 10068644 Term: Brain stem stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0 Level: PT Classification code 10071043 Term: Basal ganglia stroke System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001953-33-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

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)
•Age < 35
•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),
or definite contraindication to either trial drug as per SmPCs.
•Unable to swallow
•Bleeding tendency (platelets<100, active peptic ulcer, taking anticoagulant
medication)
•Unlikely to comply with trial medication based on knowledge of past history,
lifestyle (cognitive impairment is an exclusion)
•Planned surgery during the trial period
•History of intracranial haemorrhage (subdural haematoma, subarachnoid
haemorrhage, intracerebral haemorrhage, but not asymptomatic haemorrhagic
transformation of infarction)
•Other life threatening illness
•History of drug overdose or attempted suicide or significant active mental
illness
•Pregnant or breastfeeding women, women of childbearing age not taking
contraception. Minimum contraception is an oral contraceptive.
•Prohibited medications (see sections 4.5 of the SmPCs and protocol section
6.6.3, plus no anticoagulant drugs)
•Renal impairment (creatinine clearance <25 ml/min)
•Hepatic impairment
•Current enrolment in another Clinical Trial of Investigational Medicinal
Product (CTIMP)

EXCLUSION CRITERIA FOR MRI CVR SUB-STUDY PARTICIPANTS (EDINBURGH ONLY)
•Active respiratory illness (such as moderate to severe asthma or COPD),
unable to tolerate MRI or unable to lie flat
•Claustrophobia
•Pacemaker

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified