Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

Running, not enrolling · Phase 2

Conditions studied: Intracerebral Hemorrhage, Ischemic Stroke, Spironolactone

In brief

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.

Key facts

Study ID

NCT04760717

Run by

Yale University

People needed

160

Starts

2021-03-19

Expected to finish

2026-11-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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