Controlling Hypertension After Severe Cerebrovascular Event

NCT02982655 | Completed DMC

• 1 other identifier: KY20162085-2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 26

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.

Conditions

Severe Stroke; Acute Stroke; Hypertension

Keywords

Severe Stroke; Acute Stroke; Antihypertension; mortality; disability; clinical trial

Outcome Measures

Primary Outcomes (1)

• Death or major disability (the modified Rankin scale ≥ 3)

  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 Outcomes (1)

• Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index)

  3 months after onset

Study Arms (2)

Individualized BP lowering

EXPERIMENTAL

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

Guideline recommended BP lowering

ACTIVE COMPARATOR

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

Interventions

Individualized BP lowering PROCEDURE

Guideline recommended BP lowering; Individualized BP lowering

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• 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);
• GCS on admission ≤ 12 or NIHSS on admission ≥ 11;
• 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);
• written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

You may not qualify if:

• patients who have received thrombolytic therapy, embolectomy, or decompressive craniectomy for the current stroke;
• patients with subarachnoid hemorrhage;
• 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);
• secondary to a structural abnormality in the brain (e.g. an arteriovenous malformation, intracranial aneurysm, tumor, or trauma);
• unstable vital signs and requiring the use of vasoactive agents;
• known existing dementia or prestroke disability (e.g. score 3-5 on the modified Rankin scale);
• 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 \[glomerular filtration rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL\]);
• patients who are currently participating in other investigational trials;
• patients who are considered to have a high likelihood of not adhering to the study treatment or the follow-up regimen.

Sponsors & Collaborators

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

Study Sites (26)

Ankang Central Hospital

Ankang, Shaanxi, 725000, China

Location

Baoji Central Hospital

Baoji, Shaanxi, China

Location

Hanzhong Central Hospital

Hanzhong, Shaanxi, 710000, China

Location

Shangluo Central Hospital

Shangluo, Shaanxi, 726000, China

Location

Tongchuan Mining Hospital

Tongchuan, Shaanxi, China

Location

Tongchuan People's Hospital

Tongchuan, Shaanxi, China

Location

Weinan Central Hospital

Weinan, Shaanxi, China

Location

Xi'an 141 Hospital

Xi'an, Shaanxi, 710000, China

Location

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

Location

521 Hospital of NORINCO Group

Xi'an, Shaanxi, China

Location

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, China

Location

Xi'an Central Hospital

Xi'an, Shaanxi, China

Location

Xi'an Gaoxin Hospital

Xi'an, Shaanxi, China

Location

Xi'an No.3 Hospital

Xi'an, Shaanxi, China

Location

Xi'an No.4 Hospital

Xi'an, Shaanxi, China

Location

Xi'an No.9 Hospital

Xi'an, Shaanxi, China

Location

Xi'an Traditional Chinese Medicine Hospital

Xi'an, Shaanxi, China

Location

Xi'an XD Group Hospital

Xi'an, Shaanxi, China

Location

Xianyang Central Hospital

Xianyang, Shaanxi, 712000, China

Location

215 Hospital of Shaanxi NI

Xianyang, Shaanxi, 712021, China

Location

Yan'an University Affiliated Hospital

Ya'an, Shaanxi, China

Location

Yulin No.2 Hospital

Yulin, Shaanxi, 719000, China

Location

Yulin No.1 Hospital

Yulin, Shaanxi, China

Location

Related Publications (15)

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  PMID: 21316752 BACKGROUND

• Vemmos KN, Spengos K, Tsivgoulis G, Zakopoulos N, Manios E, Kotsis V, Daffertshofer M, Vassilopoulos D. Factors influencing acute blood pressure values in stroke subtypes. J Hum Hypertens. 2004 Apr;18(4):253-9. doi: 10.1038/sj.jhh.1001662.

  PMID: 15037874 BACKGROUND

• AlSibai A, Qureshi AI. Management of Acute Hypertensive Response in Patients With Ischemic Stroke. Neurohospitalist. 2016 Jul;6(3):122-9. doi: 10.1177/1941874416630029. Epub 2016 Apr 21.

  PMID: 27366297 BACKGROUND

• Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

  PMID: 23370205 BACKGROUND

• CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.

  PMID: 9186381 RESULT

• Qureshi AI, Ezzeddine MA, Nasar A, Suri MF, Kirmani JF, Hussein HM, Divani AA, Reddi AS. Prevalence of elevated blood pressure in 563,704 adult patients with stroke presenting to the ED in the United States. Am J Emerg Med. 2007 Jan;25(1):32-8. doi: 10.1016/j.ajem.2006.07.008.

  PMID: 17157679 RESULT

• Castillo J, Leira R, Garcia MM, Serena J, Blanco M, Davalos A. Blood pressure decrease during the acute phase of ischemic stroke is associated with brain injury and poor stroke outcome. Stroke. 2004 Feb;35(2):520-6. doi: 10.1161/01.STR.0000109769.22917.B0. Epub 2004 Jan 15.

  PMID: 14726553 RESULT

• Schrader J, Luders S, Kulschewski A, Berger J, Zidek W, Treib J, Einhaupl K, Diener HC, Dominiak P; Acute Candesartan Cilexetil Therapy in Stroke Survivors Study Group. The ACCESS Study: evaluation of Acute Candesartan Cilexetil Therapy in Stroke Survivors. Stroke. 2003 Jul;34(7):1699-703. doi: 10.1161/01.STR.0000075777.18006.89. Epub 2003 Jun 19.

  PMID: 12817109 RESULT

• Potter JF, Robinson TG, Ford GA, Mistri A, James M, Chernova J, Jagger C. Controlling hypertension and hypotension immediately post-stroke (CHHIPS): a randomised, placebo-controlled, double-blind pilot trial. Lancet Neurol. 2009 Jan;8(1):48-56. doi: 10.1016/S1474-4422(08)70263-1. Epub 2008 Dec 4.

  PMID: 19058760 RESULT

• Robinson TG, Potter JF, Ford GA, Bulpitt CJ, Chernova J, Jagger C, James MA, Knight J, Markus HS, Mistri AK, Poulter NR; COSSACS Investigators. Effects of antihypertensive treatment after acute stroke in the Continue or Stop Post-Stroke Antihypertensives Collaborative Study (COSSACS): a prospective, randomised, open, blinded-endpoint trial. Lancet Neurol. 2010 Aug;9(8):767-75. doi: 10.1016/S1474-4422(10)70163-0.

  PMID: 20621562 RESULT

• He J, Zhang Y, Xu T, Zhao Q, Wang D, Chen CS, Tong W, Liu C, Xu T, Ju Z, Peng Y, Peng H, Li Q, Geng D, Zhang J, Li D, Zhang F, Guo L, Sun Y, Wang X, Cui Y, Li Y, Ma D, Yang G, Gao Y, Yuan X, Bazzano LA, Chen J; CATIS Investigators. Effects of immediate blood pressure reduction on death and major disability in patients with acute ischemic stroke: the CATIS randomized clinical trial. JAMA. 2014 Feb 5;311(5):479-89. doi: 10.1001/jama.2013.282543.

  PMID: 24240777 RESULT

• Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.

  PMID: 18396107 RESULT

• Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

  PMID: 23713578 RESULT

• Yuan F, Yang F, Zhao J, Fu F, Liu Y, Xue C, Wang K, Yuan X, Li D, Liu Q, Zhang W, Jia Y, He J, Zhou J, Wang X, Lv H, Huo K, Li Z, Zhang B, Wang C, Li L, Li H, Jiang W. Controlling Hypertension After Severe Cerebrovascular Event (CHASE): A randomized, multicenter, controlled study. Int J Stroke. 2021 Jun;16(4):456-465. doi: 10.1177/1747493020932784. Epub 2020 Jun 11.

  PMID: 32525464 DERIVED

• Yuan F, Yang F, Xue C, Wang K, Liu Q, Zhou J, Fu F, Wang X, Zhang W, Liu Y, Huo K, Lv H, Jiang W; CHASE Study Group. Controlling Hypertension After Severe Cerebrovascular Event (CHASE): study protocol for a randomized controlled trial. Trials. 2018 Feb 21;19(1):130. doi: 10.1186/s13063-018-2530-x.

  PMID: 29467025 DERIVED

MeSH Terms

Conditions

Stroke; Hypertension

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wen Jiang, PhD

  Department of Neurology, Xijing Hospital, Fourth Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: April 2, 2019

Record last verified: 2018-09

Locations

CN (26)