NCT03028298

Sildenafil for DCI

Sildenafil for the Treatment of Delayed Cerebral Ischemia Following Subarachnoid Hemorrhage

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Each year, approximately 30,000 people in the United States suffer an intra-cranial hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will go on to have further neurological injury secondary to stroke (delayed cerebral ischemia) caused by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that the medication sildenafil, given intravenously, improves vasospasm, but has an associated degree of hypotension. The degree of hypotension was well within safety thresholds for these patients. Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V). The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does not result in as much hypotension. Specifically, the investigators look to show that comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an intravenous dose while the degree of hypotension is reduced. Additionally, using measurements of cerebral blood flow regulation acquired using transcranial Doppler ultrasound, the investigators look to show that oral sildenafil produces the same degree of improvement in vasospasm and blood flow regulation.

Conditions

• Subarachnoid Hemorrhage
• Cerebral Vasospasm

Interventions

Type	Name	Description
DRUG	Low dose sildenafil citrate
DRUG	High dose sildenafil citrate

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-12-01
• Completion: 2023-07-01
• First posted: 2017-01-23
• Last updated: 2021-06-08

Locations

1 site across 1 country: United States