Could a common pill protect stroke survivors from another stroke?
NCT ID NCT04760717
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether adding spironolactone to standard blood pressure treatment helps lower blood pressure more effectively in people who have had a stroke. About 160 adults who had a bleeding or clot-caused stroke are taking spironolactone or continuing their usual care. Researchers measure home blood pressure after 3 months to see if the drug makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spironolactone
- What this could lead to
- If it works, this could point toward a better way to manage blood pressure after a stroke, potentially reducing the risk of another stroke.
- What could go wrong
- This is a small, early-phase trial. Spironolactone may not lower blood pressure more than standard treatments, and it can cause side effects like high potassium levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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160 people
The number who actually took part.
- Started
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Mar 2021
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years 2. 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. 3. Written, informed consent by patient or surrogate 4. Ability to comply with all study procedures and available for the duration of the study Exclusion Criteria: 1. Secondary ICH due to trauma, vascular malformation, or tumor 2. Life expectancy \< 1 year 3. eGFR \<45 4. Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment 5. Known hypersensitivity to spironolactone 6. Upper arm greater than 17 inches in circumference 7. Pregnancy, planned pregnancy, or breastfeeding 8. Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria) 9. Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization 10. Systolic BP \<120 mmHg at the time of randomization 11. Any condition which, in the judgement of the investigator, increases the risk to the patient 12. History of Addison's disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
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University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06512, United States
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