Controlling Hypertension After Severe Cerebrovascular Event (CHASE)
Severe Stroke, Acute Stroke, Hypertension
About this trial
This is an interventional treatment trial for Severe Stroke focused on measuring Severe Stroke, Acute Stroke, Antihypertension, mortality, disability, clinical trial
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years;
- the randomly assigned BP-lowering regimen is able to be commenced within 72 h after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain (if the precise timing of the onset of symptoms or signs of the qualifying event is unknown, then the time of onset will be taken as the last time the patient was known to be well);
- GCS on admission ≤ 12 or NIHSS on admission ≥ 11;
- there are at least two SBP measurements of ≥ 150 and ≤ 210 mmHg, recorded ≥5 min apart (patients with an initial SBP < 150 mmHg may be randomized when the SBP fulfils entry criteria on rechecking up to 72 h after the onset of stroke);
- written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.
Exclusion Criteria:
- patients who have received thrombolytic therapy, embolectomy, or decompressive craniectomy for the current stroke;
- patients with subarachnoid hemorrhage;
- known definite contraindication to acute BP lowering (e.g. known severe carotid, vertebral, or cerebral arterial stenosis, Moyamoya disease or Takayasu's arteritis, high grade stenotic valvular heart disease);
- secondary to a structural abnormality in the brain (e.g. an arteriovenous malformation, intracranial aneurysm, tumor, or trauma);
- unstable vital signs and requiring the use of vasoactive agents;
- known existing dementia or prestroke disability (e.g. score 3-5 on the modified Rankin scale);
- concomitant medical illness that would interfere with the outcome assessments and/or follow-up (advanced cancer; severe pulmonary dysfunction [forced expiratory volume in 1 s < 50%]; severe cardiac dysfunction [ejection fraction ≤ 50%]; severe hepatic failure [Child-Pugh score ≥ 7]; severe renal failure [glomerular filtration rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL]);
- patients who are currently participating in other investigational trials;
- patients who are considered to have a high likelihood of not adhering to the study treatment or the follow-up regimen.
Sites / Locations
- Ankang Central Hospital
- Baoji Central Hospital
- Hanzhong Central Hospital
- Shangluo Central Hospital
- Tongchuan Mining Hospital
- Tongchuan People's Hospital
- Weinan Central Hospital
- Xi'an 141 Hospital
- Department of Neurology, Xijing Hospital, Fourth Military Medical University
- Tangdu Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- Shaanxi Provincial People's Hospital
- 521 Hospital of NORINCO Group
- The First Affiliated Hospital of Xi'an Medical University
- Xi'an Central Hospital
- Xi'an Gaoxin Hospital
- Xi'an No.3 Hospital
- Xi'an No.4 Hospital
- Xi'an No.9 Hospital
- Xi'an Traditional Chinese Medicine Hospital
- Xi'an XD Group Hospital
- Xianyang Central Hospital
- 215 Hospital of Shaanxi NI
- Yan'an University Affiliated Hospital
- Yulin No.2 Hospital
- Yulin No.1 Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Individualized BP lowering
Guideline recommended BP lowering
Management policy is to lower the systolic or diastolic BP by 10-15% within 2 hours of randomization and sustained for 7 days. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
Patients received management of BP based on the standard guidelines at the time, as published by the Chinese Society of Neurology (CSN) in 2014. The attending clinician may consider commencing BP treatment and sustained for 7 days if the systolic BP > 200 mmHg or diastolic BP >110 mmHg in patients with ischemic stroke, and systolic BP > 180 mmHg or diastolic BP > 110 mmHg in patients with cerebral hemorrhage.