Effect of Tadalafil on Cerebral Large Arteries in Stroke (NCT02801032) | Clinical Trial Compass
CompletedPhase 2
Effect of Tadalafil on Cerebral Large Arteries in Stroke
Denmark20 participantsStarted 2016-11-29
Plain-language summary
In a double blind placebo-controlled cross-over study the effect of tadalafil on blood flow velocity in the large arteries of the brain, cortical brain oxygenation, peripheral endothelial function, and endothelial biomarkers will be tested in patients with lacunar stroke caused by cerebral small vessel disease.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Clinical evidence of cerebral small vessel disease can be:
✓. lacunar stroke syndrome with symptoms lasting \>24 hours occurring at least 5 months previously; OR
✓. transient ischemic attack (TIA) 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 ten days of TIA, a lacunar infarction in an anatomically appropriate position is demonstrated on a subsequent MRI.
✓. Age ≥ 50 years.
✓. 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.
Exclusion criteria
✕. Known diagnosis of dementia
✕. Pregnancy or nursing
✕. Cortical infarction (\>1.5 cm maximum diameter)
✕. Systolic BP \< 90 and/or diastolic BP \< 50
✕. eGFR \< 30 ml/min/1,73m2
✕. Severe hepatic impairment
What they're measuring
1
Difference in Blood flow velocity change in middel cerebral artery (MCA) between placebo and tadalafil
Timeframe: Measurement before and up to three hours after intake of tadalafil/placebo.
2
Difference in cortical brain oxygenation between placebo and tadalafil
Timeframe: Measurement before and up to three hours after intake of tadalafil/placebo.