Intracerebral HemorrhagePhase 2REDUCENCT04760717
Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
A Phase 2 study testing Spironolactone Pill in people with Intracerebral Hemorrhage and Ischemic Stroke, run by Yale University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Ischemic Stroke, Spironolactone
- What is being tested?
- Spironolactone Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Mar 2021to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- 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.
- Written, informed consent by patient or surrogate
- Ability to comply with all study procedures and available for the duration of the study
Who cannot join
- Secondary ICH due to trauma, vascular malformation, or tumor
- Life expectancy < 1 year
- eGFR <45
- 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
- Known hypersensitivity to spironolactone
- Upper arm greater than 17 inches in circumference
Show all 12Show fewer
- Pregnancy, planned pregnancy, or breastfeeding
- Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
- Systolic BP >200 mmHg or diastolic BP >110 mmHg at the time of randomization
- Systolic BP <120 mmHg at the time of randomization
- Any condition which, in the judgement of the investigator, increases the risk to the patient
- History of Addison's disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Yale New Haven Hospital
New Haven, Connecticut, 06512
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- Spironolactone Pill
- Medical subject headings
- Cerebral Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone PillDrug
Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Experimental | Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. Receives: Drug: Spironolactone Pill |
| Standard Care | No intervention | Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in home systolic blood pressure at 3 months
The average home systolic blood pressure will be measured using a home blood pressure cuff
Measured: Baseline, 3 month
Secondary outcomes (5)
Proportion of patients achieving BP < 130/80 mm Hg
The proportion of patients achieving BP < 130/80 mm Hg at 3 months will be measured
Measured: 3 months
Number of antihypertensive medications at 3 months
The number of antihypertensive medications at 3 months will be collected
Measured: 3 months
Number of antihypertensive medications at 1 year
The number of antihypertensive medications at 1 year will be collected
Measured: 1 year
Stroke, myocardial infarction, or death
Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause
Measured: 1 year
Change in modified Rankin Scale score
Measure of neurologic disability (0=no disability to 6=dead)
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start19 Mar 2021
- Primary completion2 Feb 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Kevin Sheth, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760717
- Sponsor's protocol ID
- 2000029811
- Acronym
- REDUCE
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2021
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04760717
- Acronym / sponsor ID
- REDUCE / 2000029811
- Conditions
- Intracerebral Hemorrhage, Ischemic Stroke, Spironolactone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Experimental | Drug: Spironolactone PillParticipants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. |
| Standard Care | No intervention | –Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- 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.
- Written, informed consent by patient or surrogate
- Ability to comply with all study procedures and available for the duration of the study
Key exclusion criteria (12 listed)
- Secondary ICH due to trauma, vascular malformation, or tumor
- Life expectancy < 1 year
- eGFR <45
- 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
- Known hypersensitivity to spironolactone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone PillParticipants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. | Drug | Spironolactone |
Primary outcome
Average change in home systolic blood pressure at 3 months
Time frame: Baseline, 3 month
The average home systolic blood pressure will be measured using a home blood pressure cuff
5 secondary outcomes
Proportion of patients achieving BP < 130/80 mm Hg
Time frame: 3 months
Number of antihypertensive medications at 3 months
Time frame: 3 months
Number of antihypertensive medications at 1 year
Time frame: 1 year
Stroke, myocardial infarction, or death
Time frame: 1 year
Change in modified Rankin Scale score
Time frame: Baseline, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Sheth, MD principal investigator
Yale University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone Pill in people with Intracerebral Hemorrhage and Ischemic Stroke, run by Yale University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in home systolic blood pressure at 3 months (time frame: Baseline, 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.