Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease - PASTIS

St George's University of London0 个研究点目标入组 90 人开始时间: 2015年5月13日最近更新: 2019年2月28日

试验速览

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•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 can be:
•a) lacunar stroke syndrome with symptoms lasting >24 hours, occurring at least 6 months previously; OR:
•b) transient ischaemic attack lasting < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 6 months previously AND with MRI DWI performed acutely showing lacunar infarction, OR if MRI is not performed within 10 days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI
•3. Age = 55 years.
•4. Imaging of the carotid arteries with Doppler ultrasound, CT
•angiography or MR angiography in the previous 12 months,
•demonstrating < 70% stenosis in both internal carotid arteries
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•1. Known diagnosis of dementia
•2. Cortical infarction (>1.5 cm maximum diameter)
•3. Systolic BP <90 and/or diastolic BP < 50
•4. Creatinine Clearance<50ml/min
•5. Severe hepatic impairment
•6. History of Lactose intolerance
•7. Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, vardenafil.
•8. Concomitant use of alpha-blockers e.g. alfuzosin, doxazosin, indoramin, prazosin, tamsulosin, and terazosin can all increase the risk of postural hypotension.
•9.Participants receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
•10. weight > 130kg
•11 Uncontrolled cardiac failure
•12. Persistent or paroxysmal atrial fibrillation
•13. History of gastric ulceration
•14. History of ‘sick sinus syndrome’ or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block
•15. Uncontrolled COPD
•16. Stroke or TIA within the last 6 months
•17. MRI not tolerated or contra-indicated : MRI exclusion criteria -Participant has a cardiac pacemaker; recent surgery; vascular clips; metal implants or joint replacements; have had metal fragments in their eyes; has ever worked on a lathe; has shrapnel from a war injury; possibility of pregnancy
•18. Known monogenic causes of stroke e.g.. CADASIL
•19 Unable to provide informed consent
•20. enrolled in another CTIMP study.

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