Active — Not RecruitingPhase 2

Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke

United States160 participantsStarted 2021-03-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Average change in home systolic blood pressure at 3 months

Timeframe: Baseline, 3 month

Trial details

NCT IDNCT04760717

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-02

View on ClinicalTrials.gov More Intracerebral Hemorrhage trials