Controlling Hypertension After Severe Cerebrovascular Event (CHASE)

March 30, 2019 updated by: Xijing Hospital

A Multi-center Randomised Controlled Trial to Explore the Ideal Individualized Anti-hypertension Strategies in Patients With Severe Stroke at Acute Stage

The purpose of this academic lead study is to explore ideal blood pressure targets and optimum individualized anti-hypertension strategies in acute severe stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Ankang, Shaanxi, China, 725000
        • Ankang Central Hospital
      • Baoji, Shaanxi, China
        • Baoji Central Hospital
      • Hanzhong, Shaanxi, China, 710000
        • Hanzhong Central Hospital
      • Shangluo, Shaanxi, China, 726000
        • Shangluo Central Hospital
      • Tongchuan, Shaanxi, China
        • Tongchuan Mining Hospital
      • Tongchuan, Shaanxi, China
        • Tongchuan People's Hospital
      • Weinan, Shaanxi, China
        • weinan Central Hospital
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'An JiaoTong University
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
      • Xi'an, Shaanxi, China, 710000
        • Xi'an 141 hospital
      • Xi'an, Shaanxi, China, 710032
        • Department of Neurology, Xijing Hospital, Fourth Military Medical 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 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
      • Xianyang, Shaanxi, China, 712000
        • Xianyang Central Hospital
      • Xianyang, Shaanxi, China, 712021
        • 215 Hospital of Shaanxi NI
      • Ya'an, Shaanxi, China
        • Yan'an University Affiliated Hospital
      • Yulin, Shaanxi, China, 719000
        • Yulin No.2 Hospital
      • Yulin, Shaanxi, China
        • Yulin No.1 Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Xi'an Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Tang-Du Hospital
Shangluo Central Hospital
Baoji Central Hospital
521 Hospital of NORINCO Group
Ankang Central Hospital
Weinan Central Hospital
Yan'an University Affiliated Hospital
Xi'an Gaoxin Hospital
Xi'an No.3 Hospital
Xi'an XD Group Hospital
Hanzhong Central Hospital
Xiangyang Central Hospital
The First Affiliated Hospital of Xi'an Medical University
Yulin No.1 Hospital
Tongchuan Mining Hospital
Tongchuan People's Hospital
Yulin No.2 Hospital
Xi'an 141 Hospital
215 Hospital of Shaanxi NI
Xi'an No.4 Hospital
Xi'an No.9 Hospital
Xi'an Traditional Chinese Medicine Hospital

Investigators

  • Study Director: Wen Jiang, PhD, Department of Neurology, Xijing Hospital, Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 30, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20162085-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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