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Controlling Hypertension After Severe Cerebrovascular Event (CHASE)

This study is currently recruiting participants.
Verified November 2016 by Xijing Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02982655
First Posted: December 5, 2016
Last Update Posted: November 8, 2017
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.
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
  Purpose
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 Intervention
Severe Stroke Acute Stroke Hypertension Other: Blood pressure management policies

Study Type: Interventional
Study Design: 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

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Death or major disability (defined by the modified Rankin scale) [ Time Frame: 3 months after onset ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: January 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Blood pressure management policies
Other Names:
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Urapidil
  • Esmolol
  • Clonidine
  • Enalaprilat
  • nitroprusside
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.
Other: Blood pressure management policies
Other Names:
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Urapidil
  • Esmolol
  • Clonidine
  • Enalaprilat
  • nitroprusside

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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).
  Contacts and Locations
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


Contacts
Contact: Wen Jiang, PhD 86-029-84771319 jiangwen@fmmu.edu.cn
Contact: Fang Yang, PhD 86-029-84771319 fyangx@fmmu.edu.cn

Locations
China, Shaanxi
Ankang Central Hospital Recruiting
Ankang, Shaanxi, China, 725000
Contact: Xingsheng Wang, MD       1327019765@qq.com   
Principal Investigator: Yi Liu, MD         
Hanzhong Central Hospital Recruiting
Hanzhong, Shaanxi, China, 710000
Contact: Zheng Chen, MD       297379495@qq.com   
Principal Investigator: Kangjun Wang         
Shangluo Central Hospital Recruiting
Shangluo, Shaanxi, China, 726000
Contact: Juan Li, MD       929031470@qq.com   
Principal Investigator: Jun Zhou, MD         
Xi'an 141 Hospital Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Dongjing Zhu, MD       zdjkx@sina.com   
Principal Investigator: Qiuwu Liu, MD         
Department of Neurology, Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Wen Jiang, PhD    86-029-84771319    jiangwen@fmmu.edu.cn   
Contact: Fang Yang, PhD    86-029-84771319    fyangx@fmmu.edu.cn   
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Peng Guo, MD       1443291624@qq.com   
Principal Investigator: Wei Zhang, MD         
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Kang Huo, MD       huokangster@qq.com   
Principal Investigator: Kang Huo, MD         
Shaanxi Provincial People's Hospital Recruiting
Xi'an, Shaanxi, China, 710068
Contact: Wei Di, MD       312180404@qq.com   
Principal Investigator: Hua Lv, MD         
Xianyang Central Hospital Recruiting
Xianyang, Shaanxi, China, 712000
Contact: Tao Han, MD    +8615399259050      
Principal Investigator: Changhu Xue, MD         
215 Hospital of Shaanxi NI Recruiting
Xianyang, Shaanxi, China, 712021
Contact: Dingfeng Wu, MD       peakwu72@126.com   
Principal Investigator: Feng Fu, MD         
Yulin No.2 Hospital Recruiting
Yulin, Shaanxi, China, 719000
Contact: Feihu Chang, MD       309998611@qq.com   
Principal Investigator: Xiaocheng Wang, MD         
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
Investigators
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical University
  More Information

Publications:

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02982655     History of Changes
Other Study ID Numbers: KY20162085-2
First Submitted: November 27, 2016
First Posted: December 5, 2016
Last Update Posted: November 8, 2017
Last Verified: November 2016

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
Nitroprusside
Metoprolol
Phentolamine
Labetalol
Hydralazine
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic alpha-Antagonists
Sympathomimetics
Adrenergic alpha-1 Receptor Antagonists