Controlling Hypertension After Severe Cerebrovascular Event
- Conditions
- Acute StrokeSevere StrokeHypertension
- Interventions
- Procedure: Individualized BP lowering
- Registration Number
- NCT02982655
- Lead Sponsor
- Xijing Hospital
- Brief Summary
The purpose of this academic lead study is to explore ideal blood pressure targets and optimum individualized anti-hypertension strategies in acute severe stroke.
- Detailed Description
Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on blood pressure (BP) management. Unfortunately, so far no ideal BP range has been scientifically determined for patients with acute severe stroke.
The CHASE study aims to provide reliable data on the effects of individualized anti-hypertension strategy in patients with acute severe stroke (target recruitment 250) compared to standard guideline-based management of BP (target recruitment 250). Patients presenting with acute (\<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and elevated BP (systolic blood pressure ≧150 mmHg or diastolic blood pressure ≧ 100 mmHg) will be randomly assigned to individualized anti-hypertension treatment or guideline-based treatment for 7 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized BP lowering Individualized 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. Guideline recommended BP lowering Individualized BP lowering 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.
- Primary Outcome Measures
Name Time Method Death or major disability (the modified Rankin scale ≥ 3) 3 months after onset Components of modified Rankin Scale score:0,No symptoms;1,No significant disability despite symptoms;2,Slight disability;3,Moderate disability requiring some help, but able to walk without assistance;4,Moderate severe disability;5,Severe disability;6,Death.
- Secondary Outcome Measures
Name Time Method Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index) 3 months after onset Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living
Trial Locations
- Locations (26)
Tongchuan People's Hospital
🇨🇳Tongchuan, Shaanxi, China
Xi'an 141 Hospital
🇨🇳Xi'an, Shaanxi, China
Ankang Central Hospital
🇨🇳Ankang, Shaanxi, China
Weinan Central Hospital
🇨🇳Weinan, Shaanxi, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
Department of Neurology, Xijing Hospital, Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Baoji Central Hospital
🇨🇳Baoji, Shaanxi, China
Hanzhong Central Hospital
🇨🇳Hanzhong, Shaanxi, China
Shangluo Central Hospital
🇨🇳Shangluo, Shaanxi, China
Tongchuan Mining Hospital
🇨🇳Tongchuan, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
521 Hospital of NORINCO Group
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shaanxi, China
Xi'an Central Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an No.4 Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an Gaoxin Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an No.3 Hospital
🇨🇳Xi'an, Shaanxi, China
Xianyang Central Hospital
🇨🇳Xianyang, Shaanxi, China
215 Hospital of Shaanxi NI
🇨🇳Xianyang, Shaanxi, China
Yan'an University Affiliated Hospital
🇨🇳Ya'an, Shaanxi, China
Yulin No.2 Hospital
🇨🇳Yulin, Shaanxi, China
Xi'an No.9 Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an Traditional Chinese Medicine Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'an XD Group Hospital
🇨🇳Xi'an, Shaanxi, China
Yulin No.1 Hospital
🇨🇳Yulin, Shaanxi, China