A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,368
- 试验地点
- 30
- 主要终点
- 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 ]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe disability after the event that qualified the patient for the study, defined as a modified Rankin (mRankin) scale equal to or greater than
- •Being part of another clinical trial involving interventions for cardiovascular prevention.
- •Body mass index > 45 kg/m
- •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.
研究组 & 干预措施
Intensive Control of Systolic Blood Pressure (SBP)
Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP <120 mm Hg.
干预措施: Intensive Control of Systolic Blood Pressure (SBP) (Drug)
Standard Control of Systolic Blood Pressure
Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg
干预措施: Standard control of Systolic Blood Pressure (SBP) (Drug)
结局指标
主要结局
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 ]
时间窗: From randomization; for approximately a mean of 3.5 years
Time to first event of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
次要结局
- Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke [ Time Frame: From randomization; for approximately a mean of 3.5 years ](From randomization; for approximately a mean of 3.5 years)
- Time to Unclassified Stroke(From randomization; for approximately a mean of 3.5 years)
- Time to total 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 ](From randomization; for approximately a mean of 3.5 years)
- Time to Death(From randomization; for approximately a mean of 3.5 years)
- Time to Stroke(From randomization; for approximately a mean of 3.5 years)
- Time to Hemorrhagic Stroke(From randomization; for approximately a mean of 3.5 years)
- Time to Ischemic Stroke(From randomization; for approximately a mean of 3.5 years)
- Time to Transient Ischemic Attack (TIA)(From randomization; for approximately a mean of 3.5 years)
- Time to Renal Death(From randomization; for approximately a mean of 3.5 years)
- Time to Renal Outcome(From randomization; for approximately a mean of 3.5 years)
- Time to Cardiovascular Death(From randomization; for approximately a mean of 3.5 years)
- Time to Myocardial Infarction (MI)(From randomization; for approximately a mean of 3.5 years)
- Time to Hospitalization due to Heart Failure(From randomization; for approximately a mean of 3.5 years)
- Time to Hospitalization due to Unstable Angina(From randomization; for approximately a mean of 3.5 years)
- Cognitive Impairment(From initial assessment, for approximately a mean of 3.5 years)
- Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia(From initial assessment, for approximately a mean of 3.5 years)
- Time to Mild Cognitive Impairment(From initial assessment, for approximately a mean of 3.5 years)
- Time to All-Cause Probable Dementia(From initial assessment, for approximately a mean of 3.5 years)