| Eligibility criteria |
Inclusions
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Clinical lacunar stroke syndrome
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Brain scanning with MR including diffusion imaging wherever possible,
and obtained soon after the presentation with stroke, shows either:
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a recent, relevant (in time and location) acute lacunar infarct on
diffusion MR imaging, or
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if no visible acute lacunar infarct on diffusion MR imaging then
there is no competing pathology as a cause for stroke (e.g. no
acute cortical infarct, no acute intra-cerebral haemorrhage, no
stroke mimic such as tumour, subdural haematoma), or
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if only a CT brain scan is available, then there is a small
relevant (in age and location) subcortical infarct, or if no
infarct then there is no competing pathology as a cause for stroke
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Age > 30 years
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Independent in activities of daily living (modified Rankin ? 2)
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Capacity to give consent themselves
Exclusions
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Other significant active neurological illness present since suffering
stroke (e.g. recurrent seizures, multiple sclerosis, brain tumour)
Well-controlled epilepsy present prior to the stroke, a single
seizure at onset of the stroke or provoked seizure is not an
exclusion
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Requiring assistance with activities of daily living
(Modified Rankin ? 3)
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Has been diagnosed as having dementia on formal clinical assessment
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Diagnosis of hypotension, defined as sitting systolic blood pressure
less than 100 mmHg
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Unable to swallow tablets
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Planned surgery during the trial period including carotid
endarterectomy
Note prior and apparently successful carotid endarterectomy (or other
surgery) is not an exclusion criterion and patients who would
otherwise be eligible but require endarterectomy first may be
randomised after recovery from successful endarterectomy
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Other concurrent life threatening illness
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Unlikely to be available for follow-up (e.g. moving outside or
visitor to the area)
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History of drug overdose or attempted suicide or significant
active mental illness
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Pregnant or breastfeeding women, women of childbearing age not taking
contraception. Acceptable contraception in women of childbearing age
is a "highly effective" contraceptive measure as defined by the
Clinical Trials Facilitation Group
and includes combined (oestrogen and progesterone containing) or
progesterone-only contraception associated with inhibition of
ovulation, or intrauterine device or bilateral tubal occlusion.
Contraception must be continued for up to 30 days after the end of
the IMP dosing schedule.
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Renal impairment (creatinine clearance < 25 ml/min)
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Hepatic impairment
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Current enrolment in another Clinical Trial of Investigational
Medicinal Product (CTIMP); still in extended follow-up beyond the
CTIMP primary outcome and no longer taking that trial's IMP is not an
exclusion to enrolment in LACI-2
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Unable to tolerate MRI or contraindication to MRI (claustrophobia,
pacemaker)
Exclusions (Cilostazol only)
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Allergy to Cilostazol
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Already prescribed Cilostazol
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Any contraindication to Cilostazol
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Patient is on a prohibited medication:
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Warfarin
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Acenocoumarol (Sinthrome®)
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Phenindione
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Dabigatran (Pradaxa ®)
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Apixaban (Eliquis®)
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Rivaroxaban (Xarelto®)
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Edoxaban
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Heparin
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Dalteparin (Fragmin®)
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Enoxaprain (Clexane®)
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Tinzaparin (Innohep®)
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Omeprazole — can be switched to Lansoprazole or other Proton
Pump Inhibitor
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Anagrelide
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Clarithromycin
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Erythromycin
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Diltiazem (Tildiem®)
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Itraconazole (Sporanox®)
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Boceprevir (Victrelis®)
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Ritonavir (Norvir®)
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Telaprevir (Incivo®)
Exclusions (ISMN only)
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Allergy to ISMN
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Already prescribed ISMN
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Any contraindication to ISMN (e.g. lactose intolerance) or other
regular nitrate
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Patient is on a prohibited medication:
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Avanafil (Spedra®)
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Sildenafil (Nipatra®, Viagra®, Revatio®)
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Tadalafil (Cialis®)
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Vardenafil (Levitra®)
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