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Effect of Tadalafil on Cerebral Large Arteries in Stroke

NCT02801032 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-22

No results posted yet for this study

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.

Conditions

  • Stroke, Lacunar
  • Cerebral Small Vessel Diseases

Interventions

DRUG

Tadalafil

Single dose, 20 mg capsule p.o. minimum one week apart from placebo. MRI of cerebrum before the first trial day. Transcranial Doppler to measure blood flow velocity in MCA bilaterally before and after intervention. Near-infrared spectroscopy (NIRS) to measure cortical brain oxygenation before and after intervention. EndoPAT2000 to estimate endothelial function before and after intervention. Endothelial biomarkers in blood samples before and after intervention.

DRUG

Placebo

Single dose, matching capsule p.o. minimum one week apart from active treatment. MRI of cerebrum before the first trial day. Transcranial Doppler to measure blood flow velocity in MCA bilaterally before and after intervention. Near-infrared spectroscopy (NIRS) to measure cortical brain oxygenation before and after intervention. EndoPAT2000 to estimate endothelial function before and after intervention. Endothelial biomarkers in blood samples before and after intervention.

Sponsors & Collaborators

  • Christina Kruuse

    lead OTHER

Principal Investigators

  • Christina R Kruuse, MD, PhD · Consultant Neurologist, Dept Neurology, Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-29
Primary Completion
2017-08-04
Completion
2017-08-04

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801032 on ClinicalTrials.gov