Stroke and small vessel disease. MedDRA version: 19.0 Level: LLT Classification code 10070879 Term: Cerebral small vessel ischemic disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: PT Classification code 10076994 Term: Lacunar stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Cialis
Pharmaceutical Form: Capsule
INN or Proposed INN: TADALAFIL
CAS Number: 171596-29-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmace
Sponsors
Herlev Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Radiological evidence of cerebral small vessel disease defined as: MRI evidence of lacunar infarct(s) (= 1.5 cm maximum diameter) and/or confluent deep white matter leukoaraiosis (= grade 2 on Fazekas scale). 2. Clinical evidence of cerebral small vessel disease defined as: a) lacunar stroke syndrome with symptoms lasting >24 hours, occurring at least 5 months previously; OR b) transient ischaemic attack lasting =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Known diagnosis of dementia 2. Pregnancy or nursing women 3. Cortical infarction (>1.5 cm maximum diameter) 4. Systolic BP 130kg 11. Uncontrolled cardiac failure 12. Persistent or paroxysmal atrial fibrillation 13. History of ‘sick sinus syndrome’ or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block 14. Uncontrolled COPD 15. Stroke or TIA within the last 5 months. 16. MRI not tolerated or contra-indicated : MRI exclusion criteria -Participant has a cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements that are not compatible with MRI; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury; possibility of pregnancy 17. Known monogenic causes of stroke i.e. CADASIL 18. The patient does not wish to know important results from MRI 19. Unable to provide informed consent 20. Not possible to localise a. cerebri media bilaterally on inclusion day with Transcranial Doppler.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate the effect of the phosphodiesterase-5-inhibitor (PDE-5-inhibitor) tadalafil on blood flow velocity in the brain's large arteries and cortical brain oxygenation in patients with former lacunar strokes caused by small vessel diseases.;Primary end point(s): Primary endpoint is changes in the mean blood flow velocity in the middle cerebral artery (MCA) and changes in cortical brain oxygenation.;Timepoint(s) of evaluation of this end point: Up to three hours after intake of tadalafil.;Secondary Objective: Secundary objectives is to investigate if tadalafil improves the peripheral endothelial function measured as an improved blood vessel respons in the fingers after a short occlusion of blood suply to the arm measured with EndoPAT2000. Besides that there will be a change in endothelial function markers in the blood after a single dosis of tadalafil and that these changes correspond to the measured peripheral or central blood vessel function. Feasibility of applying tadalafil in stroke patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Peripheral endothelial function measured with EndoPAT2000. Endothelial function markers in blood.;Timepoint(s) of evaluation of this end point: Up to three hours after intake of tadalafil. | — |
Countries
Denmark
Contacts
Public ContactChristina Rostrup Kruuse
Herlev Gentofte Hospital
Outcome results
None listed