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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
Must not have
History of Addison's disease
Upper arm greater than 17 inches in circumference
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a stroke or brain bleed confirmed by a scan.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Addison's disease.
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My upper arm is more than 17 inches around.
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My brain bleeding is due to an injury, blood vessel issue, or tumor.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average change in home systolic blood pressure at 3 months
Secondary study objectives
Change in modified Rankin Scale score
Number of antihypertensive medications at 1 year
Number of antihypertensive medications at 3 months
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,292 Total Patients Enrolled
42 Trials studying Stroke
3,926,843 Patients Enrolled for Stroke
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,458 Total Patients Enrolled
17 Trials studying Stroke
16,334 Patients Enrolled for Stroke

Media Library

Spironolactone (Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT04760717 — Phase 2
Stroke Research Study Groups: Spironolactone, Standard Care
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
~13 spots leftby Mar 2025
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