Controlling Hypertension After Severe Cerebrovascular Event
NCT ID: NCT02982655
Last Updated: 2019-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2017-01-31
2018-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Individualized BP lowering
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.
Individualized BP lowering
Interventions
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Individualized BP lowering
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Xi'an Central Hospital
OTHER
Shaanxi Provincial People's Hospital
OTHER
Hanzhong Central Hospital
OTHER
Yan'an University Affiliated Hospital
OTHER
Xiangyang Central Hospital
OTHER
Xi'an 141 Hospital
UNKNOWN
Shangluo Central Hospital
OTHER
215 Hospital of Shaanxi NI
OTHER
Yulin No.2 Hospital
OTHER
Yulin No.1 Hospital
UNKNOWN
Ankang Central Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Xi'an Gaoxin Hospital
OTHER
521 Hospital of NORINCO Group
OTHER
Xi'an No.3 Hospital
OTHER_GOV
Xi'an No.4 Hospital
UNKNOWN
Xi'an No.9 Hospital
UNKNOWN
Xi'an XD Group Hospital
UNKNOWN
Xi'an Traditional Chinese Medicine Hospital
OTHER
Baoji Central Hospital
OTHER
Weinan Central Hospital
OTHER
Tongchuan Mining Hospital
UNKNOWN
Tongchuan People's Hospital
UNKNOWN
Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Wen Jiang, PhD
Role: STUDY_DIRECTOR
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Locations
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Ankang Central Hospital
Ankang, Shaanxi, China
Baoji Central Hospital
Baoji, Shaanxi, China
Hanzhong Central Hospital
Hanzhong, Shaanxi, China
Shangluo Central Hospital
Shangluo, Shaanxi, China
Tongchuan Mining Hospital
Tongchuan, Shaanxi, China
Tongchuan People's Hospital
Tongchuan, Shaanxi, China
Weinan Central Hospital
Weinan, Shaanxi, China
Xi'an 141 Hospital
Xi'an, Shaanxi, China
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Tangdu Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
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
Xi'an, Shaanxi, China
Xianyang Central Hospital
Xianyang, Shaanxi, China
215 Hospital of Shaanxi NI
Xianyang, Shaanxi, China
Yan'an University Affiliated Hospital
Ya'an, Shaanxi, China
Yulin No.2 Hospital
Yulin, Shaanxi, China
Yulin No.1 Hospital
Yulin, Shaanxi, China
Countries
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References
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Sandset EC, Bath PM, Boysen G, Jatuzis D, Korv J, Luders S, Murray GD, Richter PS, Roine RO, Terent A, Thijs V, Berge E; SCAST Study Group. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial. Lancet. 2011 Feb 26;377(9767):741-50. doi: 10.1016/S0140-6736(11)60104-9.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KY20162085-2
Identifier Type: -
Identifier Source: org_study_id
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