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Diuretic

Spironolactone for Stroke Recovery (REDUCE Trial)

Phase 2

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours.

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

REDUCE Trial Summary

This trial will compare two blood pressure treatment regimens in people who have had a brain hemorrhage. One treatment regimen will include spironolactone and the other will not. Researchers will measure blood pressure levels to see which treatment is more effective.

Who is the study for?

This trial is for adults over 18 who've had a stroke confirmed by CT or MRI, or have persistent symptoms of ischemic injury. They must be able to follow the study plan and not be pregnant, breastfeeding, or planning pregnancy. People with life expectancy under a year, severe kidney issues, high potassium levels, large upper arm circumference (>17 inches), extreme blood pressure values, Addison's disease or allergies to spironolactone can't join.Check my eligibility

What is being tested?

The study is testing if adding the pill spironolactone to regular blood pressure treatments helps better control blood pressure in people recovering from strokes compared to standard treatment without it.See study design

What are the potential side effects?

Spironolactone may cause side effects like increased potassium levels which could affect heart rhythm, kidney problems, hormonal changes (like breast enlargement in men), digestive issues and skin rashes.

REDUCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a stroke or brain bleed confirmed by a scan.

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I am 18 years old or older.

REDUCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average change in home systolic blood pressure at 3 months

Secondary outcome measures

Change in modified Rankin Scale score

Number of antihypertensive medications at 1 year

Number of antihypertensive medications at 3 months

+2 more

REDUCE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SpironolactoneExperimental Treatment1 Intervention

Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Group II: Standard CareActive Control1 Intervention

Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,426 Total Patients Enrolled

10 Trials studying Ischemic Stroke

20,814 Patients Enrolled for Ischemic Stroke

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,241 Total Patients Enrolled

9 Trials studying Ischemic Stroke

2,482 Patients Enrolled for Ischemic Stroke

Media Library

Spironolactone (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT04760717 — Phase 2

Ischemic Stroke Research Study Groups: Spironolactone, Standard Care

Ischemic Stroke Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT04760717 — Phase 2

Spironolactone (Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04760717 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are hosting this clinical investigation?

"Many hospitals across the United States are participating in this clinical trial, including Temple University Hospital (Philadelphia, Pennsylvania), Wake Forest Baptist Health (Winston-Salem, North carolina) and Yale New Haven Hospital (New Haven Connecticut)."

Answered by AI

Are there any health risks associated with using Spironolactone Pill?

"A score of 2 was assigned to spironolactone pill due to the lack of clinical data supporting its efficacy, although there is some evidence that it may be safe."

Answered by AI

Are there any vacancies open for prospective participants in this investigation?

"According to the clinical data hosted on clinicialtrials.gov, this research is currently in search of participants with an initial post date of March 19th 2021 and a most recent edit on November 22nd 2022."

Answered by AI

What is the standard protocol for utilizing Spironolactone Pill?

"Spironolactone Pill is traditionally used to treat primary hyperaldosteronism but may also be beneficial for those with cirrhosis of the liver, post-operation care plans, and acne."

Answered by AI

Are there any antecedent studies involving Spironolactone Pill?

"This particular drug was initially tested in a clinical trial at Brigham and Women's Hospital back in 2013. Over the past 8 years, there have been 90 trials completed with an additional 28 still running - many of which are located in Philadelphia, Pennsylvania."

Answered by AI

How many participants are partaking in this clinical trial?

"This clinical trial necessitates 200 patients that conform to the pre-defined inclusions. Potential participants can opt into this study at Temple University Hospital, Philadelphia or Wake Forest Baptist Health, Winston-Salem."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

2021. "Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04760717.

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