Clinical trial NCT02982655: Controlling Hypertension After Severe Cerebrovascular Event
Official title: A Multi-center Randomised Controlled Trial to Explore the Ideal Individualized Anti-hypertension Strategies in Patients With Severe Stroke at Acute Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Stroke
Acute Stroke
Hypertension
Keywords: Severe Stroke
Acute Stroke
Antihypertension
mortality
disability
clinical trial
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Tang-Du Hospital
name: Xi'an Central Hospital
name: Shaanxi Provincial People's Hospital
name: Hanzhong Central Hospital
name: Yan'an University Affiliated Hospital
name: Xiangyang Central Hospital
name: Xi'an 141 Hospital
name: Shangluo Central Hospital
name: 215 Hospital of Shaanxi NI
name: Yulin No.2 Hospital
name: Yulin No.1 Hospital
name: Ankang Central Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Xi'an Gaoxin Hospital
name: 521 Hospital of NORINCO Group
name: Xi'an No.3 Hospital
name: Xi'an No.4 Hospital
name: Xi'an No.9 Hospital
name: Xi'an XD Group Hospital
name: Xi'an Traditional Chinese Medicine Hospital
name: Baoji Central Hospital
name: Weinan Central Hospital
name: Tongchuan Mining Hospital
name: Tongchuan People's Hospital
First posted: 2016-12-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years;
2. 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);
3. GCS on admission ≤ 12 or NIHSS on admission ≥ 11;
4. 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);
5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

Exclusion Criteria:

1. patients who have received thrombolytic therapy, embolectomy, or decompressive craniectomy for the current stroke;
2. patients with subarachnoid hemorrhage;
3. 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);
4. secondary to a structural abnormality in the brain (e.g. an arteriovenous malformation, intracranial aneurysm, tumor, or trauma);
5. unstable vital signs and requiring the use of vasoactive agents;
6. known existing dementia or prestroke disability (e.g. score 3-5 on the modified Rankin scale);
7. 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 \[glomerular filtration rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL\]);
8. patients who are currently participating in other investigational trials;
9. patients who are considered to have a high likelihood of not adhering to the study treatment or the follow-up regimen.

Primary outcomes:
measure: Death or major disability (the modified Rankin scale ≥ 3)
timeFrame: 3 months after onset
Secondary outcomes:
measure: Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index)
timeFrame: 3 months after onset
Other outcomes:
Locations:
city: Ankang
country: China
facility: Ankang Central Hospital
state: Shaanxi
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shaanxi
city: Hanzhong
country: China
facility: Hanzhong Central Hospital
state: Shaanxi
city: Shangluo
country: China
facility: Shangluo Central Hospital
state: Shaanxi
city: Tongchuan
country: China
facility: Tongchuan Mining Hospital
state: Shaanxi
city: Tongchuan
country: China
facility: Tongchuan People's Hospital
state: Shaanxi
city: Weinan
country: China
facility: Weinan Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an 141 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Department of Neurology, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: 521 Hospital of NORINCO Group
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Gaoxin Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an No.3 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an No.4 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an No.9 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Traditional Chinese Medicine Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an XD Group Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang Central Hospital
state: Shaanxi
city: Xianyang
country: China
facility: 215 Hospital of Shaanxi NI
state: Shaanxi
city: Ya'an
country: China
facility: Yan'an University Affiliated Hospital
state: Shaanxi
city: Yulin
country: China
facility: Yulin No.2 Hospital
state: Shaanxi
city: Yulin
country: China
facility: Yulin No.1 Hospital
state: Shaanxi
Study officials:
affiliation: Department of Neurology, Xijing Hospital, Fourth Military Medical University
name: Wen Jiang, PhD
role: STUDY_DIRECTOR
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