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Severe StrokeCHASENCT02982655

Controlling Hypertension After Severe Cerebrovascular Event

A study testing Individualized BP lowering in people with Severe Stroke and Acute Stroke, run by Xijing Hospital at 26 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Stroke, Acute Stroke, Hypertension
What is being tested?
Individualized BP lowering
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
26 sitesChina
Study dates
Jan 2017to 30 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 9Show fewer
  • 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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

China26 sites

  • Ankang Central Hospital

    Ankang, Shaanxi, 725000

  • Baoji Central Hospital

    Baoji, Shaanxi

  • Hanzhong Central Hospital

    Hanzhong, Shaanxi, 710000

  • Shangluo Central Hospital

    Shangluo, Shaanxi, 726000

  • Tongchuan Mining Hospital

    Tongchuan, Shaanxi

  • Tongchuan People's Hospital

    Tongchuan, Shaanxi

  • Weinan Central Hospital

    Weinan, Shaanxi

  • Xi'an 141 Hospital

    Xi'an, Shaanxi, 710000

  • Department of Neurology, Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710032

  • Tangdu Hospital

    Xi'an, Shaanxi, 710038

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • 521 Hospital of NORINCO Group

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi

  • Xi'an Central Hospital

    Xi'an, Shaanxi

  • Xi'an Gaoxin Hospital

    Xi'an, Shaanxi

  • Xi'an No.3 Hospital

    Xi'an, Shaanxi

  • Xi'an No.4 Hospital

    Xi'an, Shaanxi

  • Xi'an No.9 Hospital

    Xi'an, Shaanxi

  • Xi'an Traditional Chinese Medicine Hospital

    Xi'an, Shaanxi

  • Xi'an XD Group Hospital

    Xi'an, Shaanxi

  • Xianyang Central Hospital

    Xianyang, Shaanxi, 712000

  • 215 Hospital of Shaanxi NI

    Xianyang, Shaanxi, 712021

  • Yan'an University Affiliated Hospital

    Ya'an, Shaanxi

  • Yulin No.2 Hospital

    Yulin, Shaanxi, 719000

  • Yulin No.1 Hospital

    Yulin, Shaanxi

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Individualized BP lowering
Keywords
Severe Stroke, Acute Stroke, Antihypertension, mortality, disability, clinical trial
Medical subject headings
Stroke, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized BP loweringProcedure or surgery

Study groups in NCT02982655
Study groupRoleWhat they receive
Individualized BP loweringExperimentalManagement 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.
Receives: Procedure: Individualized BP lowering
Guideline recommended BP loweringActive comparatorPatients 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.
Receives: Procedure: Individualized BP lowering

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months after onset

Secondary outcomes (1)

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

    Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living

    Measured: 3 months after onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02982655
Sponsor's protocol ID
KY20162085-2
Acronym
CHASE
Status last verified
Sep 2018
First submitted
27 Nov 2016
Last updated
2 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21316752

  • 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.

    PubMed 15037874

  • 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.

    PubMed 27366297

  • 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.

    PubMed 23370205

  • 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.

    PubMed 9186381

  • 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.

    PubMed 17157679

  • 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.

    PubMed 14726553

  • 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.

    PubMed 12817109

  • 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.

    PubMed 19058760

  • 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.

    PubMed 20621562

  • 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.

    PubMed 24240777

  • 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.

    PubMed 18396107

  • 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.

    PubMed 23713578

  • 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.

    PubMed 32525464

  • 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.

    PubMed 29467025

Questions about this trial

What is this clinical trial studying?

A study testing Individualized BP lowering in people with Severe Stroke and Acute Stroke, run by Xijing Hospital at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death or major disability (the modified Rankin scale ≥ 3) (time frame: 3 months after onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02982655, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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