ClinicalTrials.gov
ClinicalTrials.gov Menu

Controlling Hypertension After Severe Cerebrovascular Event (CHASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02982655
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
Tang-Du Hospital
Xi'an Central Hospital
Shaanxi Provincial People's Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Information provided by (Responsible Party):
Xijing Hospital

November 27, 2016
December 5, 2016
November 8, 2017
January 2017
December 2022   (Final data collection date for primary outcome measure)
Death or major disability (defined by the modified Rankin scale) [ Time Frame: 3 months after onset ]
Same as current
Complete list of historical versions of study NCT02982655 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
Other: Blood pressure management policies
Other Names:
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Urapidil
  • Esmolol
  • Clonidine
  • Enalaprilat
  • nitroprusside
  • Experimental: Individualized BP lowering
    Management policy is to lower the systolic or diastolic BP by 10-15% within 24 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: Other: Blood pressure management policies
  • 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: Other: Blood pressure management policies

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Same as current
December 2022
December 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe stroke occurred in 72 hours.
  • GCS ≤12 or NIHSS≥11.
  • Systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg on admission.
  • Able to be 'actively' treated and admitted to a monitored facility.
  • Informed consent.

Exclusion Criteria:

  • Received intravenous thrombolytic therapy.
  • Concurrent severe heart failure.
  • Concurrent acute myocardial infarction.
  • Concurrent unstable angina.
  • Concurrent severe systemic diseases.
  • Other serious or life-threatening disease before the stroke.
  • Clear indication, in the clinician's view, for antihypertensive therapy during the acute phase of stroke (i.e. multiple cerebral artery stenosis, apparent cerebrovascular malformation or aortic dissection, or other situations).
  • Patient unavailable for follow-up (e.g. no fixed address).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Wen Jiang, PhD 86-029-84771319 jiangwen@fmmu.edu.cn
Contact: Fang Yang, PhD 86-029-84771319 fyangx@fmmu.edu.cn
China
 
 
NCT02982655
KY20162085-2
Yes
Not Provided
Not Provided
Xijing Hospital
Xijing Hospital
  • Tang-Du Hospital
  • Xi'an Central Hospital
  • Shaanxi Provincial People's Hospital
  • Hanzhong Central Hospital
  • Yan'an University Affiliated Hospital
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xijing Hospital
November 2016

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