Could a viagra drug shield the brain from stroke damage?
NCT ID NCT03855332
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether sildenafil, a drug used for erectile dysfunction, can reduce harmful pulsations in brain blood flow in 75 people who had a stroke or mini-stroke due to small vessel disease. Participants took sildenafil, a similar drug (cilostazol), or a placebo for three weeks each. The goal was to see if these drugs could lower the pressure spikes hitting the brain, potentially slowing the progression of small vessel disease, which affects millions and causes stroke and dementia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sildenafil
- What this could lead to
- If it works, this could point toward the first effective treatment for small vessel disease, a common cause of stroke and dementia.
- What could go wrong
- This is a small, early-phase trial (75 people) testing a short-term effect on a measurement, not on long-term outcomes. The drug may not reduce disease progression or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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75 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jan 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * Can record MCA waveform on at least one side ('useable TCD window') * Non-disabling, ischaemic stroke or TIA, \>1 month prior to randomisation, of either cryptogenic or lacunar aetiology, confirmed clinically or on brain imaging * White matter hyperintensities on MRI (Fazekas scale) or CT (Blennow scale) consistent with cerebral small vessel disease * Age below 60 MRI Fazekas score 1 to 3 (max 2 points in periventricular or deep score) or CT Blennow score 1 to 3 (max 2 points in periventricular or deep score) * Age above 60 MRI Fazekas score 1 to 4 (max 2 points in periventricular or deep score) or CT Blennow score 1 to 4 (max 2 points in periventricular or deep score) Exclusion Criteria: * Pregnant or breastfeeding women, women of childbearing age not taking contraception. * Other major neurological or psychiatric conditions affecting the brain and interfering with the study design (e.g. multiple sclerosis) * Other causes of stroke such as * ≥50% luminal stenosis (NASCET) in large arteries supplying the infarct area * major-risk cardioembolic source of embolism (permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumours, mitral stenosis, recent (\<4 weeks) myocardial infarction, left ventricular ejection fraction less than 30%, valvular vegetations, or infective endocarditis) * other specific causes of stroke (e.g. arteritis, dissection, drug misuse) * Large vessel occlusion on MRA or CTA (carotid, basilar or MCA) * Modified Rankin Score \>3 * Unable to swallow * Renal impairment (eGFR \<35ml/min) * Significant biochemical abnormalities (sodium \<130, K+ \<2.5 or \>5.5, LFTs \>3 x upper limit of normal range) * Life expectancy \<2 years * Contraindication to active agents * Concurrent use of alphablocker * Regular use of nitrate (ISMN, GTN, other) * Heart failure (NYHA 2-4) * Severe aortic stenosis * Bilateral renal artery stenosis * Uncontrolled arrhythmias * Previous priapism * Anatomical deformation of the penis * Recent myocardial infarction (within 6 months) * Unstable angina * History of non-arteritic ischaemic optic neuropathy * Hypotension: BP \<90/60 * Haemodynamically significant aortic / mitral valve disease * Sickle cell disease, myeloma, leukaemia * Uncontrolled hypertension (BP \>180/110 despite treatment with 3 antihypertensives) * Scheduled elective surgery or other procedures requiring general anaesthesia during the study. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study or the participant's ability to participate in the study. * Participants who have participated in another research study involving an investigational product in the past 12 weeks. * Use of an anticoagulant (warfarin, dabigatran, rivaroxaban etc) or more than one antiplatelet drug. * Predisposition to intracerebral haemorrhage (previous ICH, likely cerebral amyloid angiopathy) or intraocular haemorrhage (uncontrolled diabetic retinopathy or neovascularisation) * Allergy to constituents of medications or components of placebo / overencapsulation * Use of CYP inducers that interact with study medications (ketoconazole, erythromycin). Exclusion criteria specific for MRI substudy * Not able to transfer to MRI scanner * Active respiratory illness (such as moderate to severe asthma or COPD) such that they are unable to tolerate MRI or unable to lie flat * Claustrophobia * Contraindication to MRI scan (pacemaker, aneurysm clip etc)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Oxford
Oxford, Oxon, OX39DU, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.