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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

November 27, 2016
December 5, 2016
September 13, 2018
January 2017
December 2018   (Final data collection date for primary outcome measure)
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.
Death or major disability (defined by the modified Rankin scale) [ Time Frame: 3 months after onset ]
Complete list of historical versions of study NCT02982655 on ClinicalTrials.gov Archive Site
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
  • Death or major disability (defined by the modified Rankin scale) [ Time Frame: 14 days after onset ]
  • National Institute of Health stroke scale [ Time Frame: 14 days after onset ]
  • National Institute of Health stroke scale [ Time Frame: 3 months after onset ]
  • Symptomatic hypotension [ Time Frame: 7 days ]
  • Renal failure [ Time Frame: 7 days ]
  • Blood coagulation disorder [ Time Frame: 7 days ]
  • Adverse Events That Are Related to Treatment [ Time Frame: 7 days ]
Not Provided
Not Provided
 
Controlling Hypertension After Severe Cerebrovascular Event
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Severe Stroke
  • Acute Stroke
  • Hypertension
Procedure: Individualized BP lowering
  • 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.
    Intervention: 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.
    Intervention: Procedure: Individualized BP lowering

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
Same as current
May 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02982655
KY20162085-2
Yes
Not Provided
Plan to Share IPD: Undecided
Xijing Hospital
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
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xijing Hospital
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP