Who can participate?

Having a lacunar stroke increases the risk of another stroke, dementia and loss of independence.

What is the purpose of the study?

• A quarter - 25% - of strokes, called lacunar strokes, are caused by disease of the smallest blood vessels in the brain.
• The lacunar strokes are caused when small blood vessels deep within the brain become damaged and do not supply oxygen and nutrients well.
• When there is an interruption in blood supply to part of the brain, the lacunar stroke happens. It affects about 35000 people per year in the UK.
• This ‘small vessel disease’ can also cause problems with thinking, balance and walking and can sometimes lead to dementia.
• There are no treatments yet to help the small blood vessels work better.
• As a result, damage to the brain may continue to build up.

We have found two drugs that may reduce damage to the small blood vessels in the brain and therefore could prevent strokes and thinking problems due to small vessel disease.

What drugs are tested in LACI-3?

The two LACI-3 drugs are widely used to treat other diseases but have not been used to treat small vessel disease before.

• One drug, called Cilostazol, is most commonly used in the UK to treat problems with the blood supply to the legs, but is used to prevent more strokes from happening in many other countries.
• The other drug, called Isosorbide Mononitrate, is commonly used all over the world including in the UK to treat angina (pains in the chest due to poor blood supply to the heart)

We want to test if these drugs can:

• help prevent the small vessel disease from causing another stroke or affecting the thinking skills
• if they can be used safely in patients with a lacunar stroke
• and if they can be taken over several years.

✅ You may be able to take part if:

• You are 30 years or older.
• You have had a lacunar stroke, confirmed by a brain scan, or your symptoms strongly suggest this type of stroke with no other cause.
• You are able to understand the study and give informed consent.
• You may also be eligible if you have a genetic condition affecting small blood vessels (like CADASIL), as long as it caused a lacunar stroke.

❌ You cannot take part if:

• It has been less than 24 hours since your stroke or you are currently taking two blood-thinning medications.
• Your stroke was caused by a known, treatable cause, such as a blood clot from the heart or a blocked neck artery.
• You have had another recent brain condition, such as a bleed, tumour, or larger stroke affecting the brain surface.
• You have another serious brain or nerve disorder (e.g., brain tumour, multiple sclerosis). Well-controlled epilepsy before your stroke, or a single seizure at stroke onset, is allowed.
• You are unable to swallow tablets.
• You are seriously dependent on others for daily care.
• You have been told you have dementia or serious memory problems.
• You are due to have major surgery during the study period (minor past surgery is fine).
• Your blood pressure is very low.
• You have serious kidney or liver disease.
• You are pregnant, breastfeeding, or could become pregnant and are not using reliable contraception.
• You are unlikely to be available for follow-up visits over the next 18 months or unlikely to follow study instructions.
• You have a recent history of overdose or attempted suicide.
• You are already taking both trial drugs or not allowed to take either for medical reasons.
• You have already taken part in LACI-3 or are in another study that doesn't allow joining LACI-3.

Specific to the trial medications:

You might still be able to take part if you can take at least one of the trial medications.

You cannot take Cilostazol (but might still take ISMN) if:

• You already take Cilostazol or your doctor has said you should not take it.
• You take other medications that interact with Cilostazol.
• You have active heart problems, such as irregular heartbeat, recent heart attack, chest pain, or heart failure.
• You have a bleeding risk, such as a low platelet count, active ulcer, or past serious brain bleed (a few small old bleeds may be okay).

You cannot take ISMN (but might still take Cilostazol) if:

• You already take ISMN or your doctor has said you should not take it.
• You take other medications that interact with ISMN.

If you're not sure whether this applies to you, don't worry—our research team can help go through it with you.

How to take part in LACI-3?

A network of 60 UK hospitals will identify patients after lacunar stroke and invite them to participate.

Patients can self-refer to the recruiting hospital.

See which hospitals are participating in LACI-3

Participant Fact Sheet: 

Click here to download a Participants Fact Sheet for the LACI-3 Trial: