Effect of Tadalafil on cerebral large arteries in stroke patients. - Tadalafil and apoplexia.

Herlev Gentofte Hospital0 个研究点开始时间: 2016年3月10日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•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;
•b) transient ischaemic attack lasting < 24 hours with limb weakness, hemi-sensory loss or dysarthria at least 5 months previously AND with MR 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 = 50 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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Known diagnosis of dementia
•2. Pregnancy or nursing women
•3.Cortical infarction (>1.5 cm maximum diameter)
•4.Systolic BP < 90 and/or diastolic BP < 50
•5.eGFR < 30 ml/min/1,73 m2
•6.Severe hepatic impairment
•7.History of Lactose intolerance
•8.Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, vardenafil
•9.Patients receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
•10.Body weight > 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.

发起方

Herlev Gentofte Hospital