Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Conditions
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Ischemic Stroke, Intracerebral Hemorrhage, Spironolactone

Intervention / Treatment
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* Drug: Spironolactone Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spironolactone<br>Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. | Drug: Spironolactone Pill<br>* Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.<br>|
| No Intervention: Standard Care<br>Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| Number of antihypertensive medications at 3 months | The number of antihypertensive medications at 3 months will be collected | 3 months | 
| Number of antihypertensive medications at 1 year | The number of antihypertensive medications at 1 year will be collected | 1 year | 
| Stroke, myocardial infarction, or death | Incidence of stroke of any type (ischemic or hemorrhagic), myocardial infarction, or death from any cause | 1 year | 
| Change in modified Rankin Scale score | Measure of neurologic disability (0=no disability to 6=dead) | Baseline, 1 year |