Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients (NCT04036409) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients
Brazil4,368 participantsStarted 2019-08-05
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.).
* Histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a mean of 3.5 years ]
Timeframe: From randomization; for approximately a mean of 3.5 years