NCT04760717

Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.

Detailed description

This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC guidelines in stroke survivors. This study will randomize a total of 200 patients, 100 white and 100 non-white patients, at least three weeks after last known normal or symptom discovery/onset of their stroke to an antihypertensive regimen with spironolactone once daily or standard BP control based on the 2017 AHA/ACC guidelines for 1 year. Participants will undergo baseline testing for neurohormonal levels and will be followed for 12 months with regular assessment of home BP readings. The primary outcome of home systolic BP will be measured at 3 months.

Conditions

• Intracerebral Hemorrhage
• Ischemic Stroke
• Spironolactone

Interventions

Type	Name	Description
DRUG	Spironolactone Pill	Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Timeline

• Start date: 2021-03-19
• Primary completion: 2026-02-02
• Completion: 2026-11-01
• First posted: 2021-02-18
• Last updated: 2026-03-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study