NCT04760717

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
5mo left

Started Mar 2021

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Mar 2021Nov 2026

First Submitted

Initial submission to the registry

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

February 16, 2021

Last Update Submit

March 20, 2026

Conditions

Intracerebral HemorrhageIschemic StrokeSpironolactone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Proportion of patients achieving BP < 130/80 mm Hg

    3 months

  • Number of antihypertensive medications at 3 months

    3 months

  • Number of antihypertensive medications at 1 year

    1 year

  • Stroke, myocardial infarction, or death

    1 year

  • Change in modified Rankin Scale score

    Baseline, 1 year

Study Arms (2)

Spironolactone

EXPERIMENTAL

Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Drug: Spironolactone Pill

Standard Care

NO INTERVENTION

Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment.

Interventions

Spironolactone PillDRUG

Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.

Spironolactone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cerebral HemorrhageIschemic Stroke

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsStroke

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kevin Sheth, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 18, 2021

Study Start

March 19, 2021

Primary Completion

February 2, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

US(5)