Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients (OPTIMAL Stroke)

Hospital Israelita Albert Einstein

Status: Active, not recruiting

Conditions: Ischemic Stroke; Cognitive Impairment; Vascular Diseases; Blood Pressure

Treatments: Drug: Intensive Control of Systolic Blood Pressure (SBP); Drug: Standard control of Systolic Blood Pressure (SBP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04036409

OPTIMAL STROKE Trial

Details and patient eligibility

About

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 major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.

Enrollment: 4,369 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,369 participants in 2 patient groups

Intensive Control of Systolic Blood Pressure (SBP)

Experimental group

Description:

Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP \<120 mm Hg.

Treatment:

Drug: Intensive Control of Systolic Blood Pressure (SBP)

Standard Control of Systolic Blood Pressure

Active Comparator group

Description:

Participants randomized into the Standard arm will have a goal of SBP \<140 mm Hg

Treatment:

Drug: Standard control of Systolic Blood Pressure (SBP)