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

St George's University of London0 sites90 target enrollmentMay 13, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 13, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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

•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