Status:
ACTIVE_NOT_RECRUITING
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Ischemic Stroke
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several m...
Eligibility Criteria
Inclusion
- History of ischemic stroke or transient ischemic attack (TIA), considered clinically stable in the 48 hours prior to inclusion in the study. (they will be classified into a recent stroke \<120 days or chronic when\> 120 days), AND
- Systolic Blood Pressure (SBP) between 130 and 180 mmHg:
- 130 -180 and use of up to one antihypertensive drug;
- 130-170 and use of up to two drugs;
- 130-160 and use of up to three drugs;
- 130-150 and use of up to four drugs. AND
Exclusion
- Severe disability after the event that qualified the patient for the study, defined as a modified Rankin (mRankin) scale equal to or greater than 4.
- Being part of another clinical trial involving interventions for cardiovascular prevention.
- Body mass index \> 45 kg/m2.
- Pregnancy or Breastfeeding.
- Secondary hypertension.
- Class IV Canadian Cardiovascular Society (CCS) Resting Angina.
- Acute coronary syndrome in the last six months
- Severe renal dysfunction with GFR \< 20 mL/min/1.73m2 calculated by the CKD-EPI equation
- Refusal to consent.
- Symptomatic heart failure - Class IV New York Heart Association (NYHA) or ejection fraction \<35% on Doppler echocardiography.
- Conditions that, at the investigators' discretion, limit the patient's participation in the study, including but not limited to the following:
- Recent history of alcohol and illicit drug abuse.
- Psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.).
- History of poor drug adherence and no attendance at consultations.
- Planning to change of address in the next four years.
- Planning to be absent from home city for more than three months in the next year.
- Residing in the same residence of another patient previously included in this study.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
4369 Patients enrolled
Trial Details
Trial ID
NCT04036409
Start Date
August 5 2019
End Date
December 1 2025
Last Update
January 3 2024
Active Locations (30)
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1
Clínica Silvestre Santé
Rio Branco, Acre, Brazil
2
Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
Maceió, Alagoas, Brazil
3
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil, 60175-295
4
Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
Fortaleza, Ceará, Brazil, 60430-372