IBIS 2019.
Study name | IBIS study |
Methods | Multicentre, randomized, controlled trial |
Participants | Inclusion criteria: men and women aged ≥ 40 years; history of symptomatic, MRI/CT‐confirmed ischaemic stroke (3–12 months since last acute onset); SBP ≥ 140 mmHg on 0 medication; 135–180 mmHg on 1 medication; 135–170 mmHg on up to 2 medications; 135–160 mmHg on up to 3 medications; or 135–150 mmHg on up to 4 medications. Exclusion criteria: documented symptomatic intracranial or extracranial stenosis (≥ 50%) (or both), or asymptomatic intracranial or extracranial stenosis (≥ 70%) (or both); disabling stroke (modified Rankin score ≥ 4); previous intracranial haemorrhage from a non‐traumatic cause; any symptoms of orthostatic hypotension during the standing blood pressure measurement, or standing SBP < 110 mmHg; severe heart failure (NYHA class III and IV) within the past 6 months or left ventricular ejection fraction (by any method) < 35%; any history of atrial fibrillation, ventricular aneurysm, or suspicion of cardioembolic pathology for stroke; other specific cause of stroke identified by routine clinical care (e.g. arteritis, dissection, migraine/vasospasm, drug abuse); dialysis, eGFR < 20 mL/minute/1.73 m², urine protein‐to‐creatinine ratio ≥ 1 g/g, or albumin‐to‐creatinine ratio ≥ 600 mg/g; planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening; a medical condition likely to limit survival to < 3 years; a cancer diagnosed and treated within the past 2 years that, in the judgement of clinical study staff, would compromise a person's ability to comply with the protocol and complete the trial (except non‐melanoma skin cancer, early‐stage prostate cancer, or localized breast cancer); any factors judged by the clinic team to be likely to limit adherence to the intervention; failure to obtain informed consent from a participant; currently participating in another intervention study; pregnant, currently trying to become pregnant, or of child‐bearing potential and not using contraception. |
Interventions | Standard target: SBP < 140 mmHg Intensive target: SBP < 120 mmHg |
Outcomes | Primary outcome: stroke event Secondary outcomes: composite major CVD events; MI; non‐MI acute coronary syndrome; heart failure; dementia; all‐cause mortality |
Starting date | July 2020 |
Contact information | Jiang He, MD, PhD; 504‐988‐5165; jhe@tulane.edu Yilong Wang, MD, PhD; 011‐86‐13911666571; yilong528@aliyun.com |
Notes | Sponsors: Tulane University and Beijing Tiantan Hospital |