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Controlling Hypertension After Severe Cerebrovascular Event (CHASE)

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ClinicalTrials.gov Identifier: NCT02982655
Recruitment Status : Active, not recruiting
First Posted : December 5, 2016
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Tang-Du Hospital
Xi'an Central Hospital
Shaanxi Provincial People's Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Xianyang Central Hospital
Xi'an 141 Hospital
Shangluo Central Hospital
215 Hospital of Shaanxi NI
Yulin No.2 Hospital
Yulin No.1 Hospital
Ankang Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Xi’an Gaoxin Hospital
521 Hospital of NORINCO Group
The First Affiliated Hospital of Xi'an Medical University
Xi'an No.3 Hospital
Xi'an No.4 Hospital
Xi'an No.9 Hospital
Xi'an XD Group Hospital
Xi'an Traditional Chinese Medicine Hospital
Baoji Central Hospital
Weinan Central Hospital
Tongchuan Mining Hospital
Tongchuan People's Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Severe Stroke Acute Stroke Hypertension Procedure: Individualized BP lowering Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: 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.
Procedure: Individualized BP lowering
Active Comparator: Guideline recommended 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.
Procedure: Individualized BP lowering



Primary Outcome Measures :
  1. Death or major disability (the modified Rankin scale ≥ 3) [ Time Frame: 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 :
  1. Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index) [ Time Frame: 3 months after onset ]
    Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982655


Locations
China, Shaanxi
Ankang Central Hospital
Ankang, Shaanxi, China, 725000
Baoji Central Hospital
Baoji, Shaanxi, China
Hanzhong Central Hospital
Hanzhong, Shaanxi, China, 710000
Shangluo Central Hospital
Shangluo, Shaanxi, China, 726000
Tongchuan Mining Hospital
Tongchuan, Shaanxi, China
Tongchuan People's Hospital
Tongchuan, Shaanxi, China
Weinan Central Hospital
Weinan, Shaanxi, China
Xi'an 141 Hospital
Xi'an, Shaanxi, China, 710000
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
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 Gaoxin Hospital
Xi'an, Shaanxi, China
Xi'an No.3 Hospital
Xi'an, Shaanxi, China
Xi'an No.4 Hospital
Xi'an, 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
Xianyang Central Hospital
Xianyang, Shaanxi, China, 712000
215 Hospital of Shaanxi NI
Xianyang, Shaanxi, China, 712021
Yan'an University Affiliated Hospital
Ya'an, Shaanxi, China
Yulin No.2 Hospital
Yulin, Shaanxi, China, 719000
Yulin No.1 Hospital
Yulin, Shaanxi, China
Sponsors and Collaborators
Xijing Hospital
Tang-Du Hospital
Xi'an Central Hospital
Shaanxi Provincial People's Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Xianyang Central Hospital
Xi'an 141 Hospital
Shangluo Central Hospital
215 Hospital of Shaanxi NI
Yulin No.2 Hospital
Yulin No.1 Hospital
Ankang Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Xi’an Gaoxin Hospital
521 Hospital of NORINCO Group
The First Affiliated Hospital of Xi'an Medical University
Xi'an No.3 Hospital
Xi'an No.4 Hospital
Xi'an No.9 Hospital
Xi'an XD Group Hospital
Xi'an Traditional Chinese Medicine Hospital
Baoji Central Hospital
Weinan Central Hospital
Tongchuan Mining Hospital
Tongchuan People's Hospital
Investigators
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical University

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02982655     History of Changes
Other Study ID Numbers: KY20162085-2
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xijing Hospital:
Severe Stroke
Acute Stroke
Antihypertension
mortality
disability
clinical trial

Additional relevant MeSH terms:
Hypertension
Stroke
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases