NCT04760717Active, not recruitingPhase 2
Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 16 Feb 2021
- Start date
- 19 Mar 2021
- Primary completion date
- 2 Feb 2026
- Lead sponsor
- Yale University
- Diseases
- Stroke
- NCT number
- NCT04760717
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 19 Mar 2021 to the primary completion date, 2 Feb 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
Other illness
- Known hypersensitivity to spironolactone
- Any condition which, in the judgement of the investigator, increases the risk to the patient
- History of Addison's disease
Lab values
- 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
Other
- Secondary ICH due to trauma, vascular malformation, or tumor
- Life expectancy \< 1 year
- Upper arm greater than 17 inches in circumference
- Pregnancy, planned pregnancy, or breastfeeding
- Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization
- Systolic BP \<120 mmHg at the time of randomization
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Temple University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Wake Forest Baptist Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.