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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02982655
Other study ID # KY20162085-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date November 30, 2018

Study information

Verified date September 2018
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. age = 18 years;

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:

1. patients who have received thrombolytic therapy, embolectomy, or decompressive craniectomy for the current stroke;

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Individualized BP lowering


Locations

Country Name City State
China 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 521 Hospital of NORINCO Group Xi'an Shaanxi
China Department of Neurology, Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi
China Shaanxi Provincial People's Hospital Xi'an Shaanxi
China Tangdu Hospital Xi'an Shaanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi
China Xi'an 141 Hospital 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 215 Hospital of Shaanxi NI Xianyang Shaanxi
China Xianyang Central Hospital Xianyang Shaanxi
China Yan'an University Affiliated Hospital Ya'an Shaanxi
China Yulin No.1 Hospital Yulin Shaanxi
China Yulin No.2 Hospital Yulin Shaanxi

Sponsors (26)

Lead Sponsor Collaborator
Xijing Hospital 215 Hospital of Shaanxi NI, 521 Hospital of NORINCO Group, Ankang Central Hospital, Baoji Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Hanzhong Central Hospital, Shaanxi Provincial People's Hospital, Shangluo Central Hospital, Tang-Du Hospital, The First Affiliated Hospital of Xi'an Medical University, Tongchuan Mining Hospital, Tongchuan People's Hospital, Weinan Central Hospital, Xi'an 141 Hospital, Xi'an Central Hospital, Xi'an No.3 Hospital, Xi'an No.4 Hospital, Xi'an No.9 Hospital, Xi'an Traditional Chinese Medicine Hospital, Xi'an XD Group Hospital, Xi’an Gaoxin Hospital, Xianyang Central Hospital, Yan'an University Affiliated Hospital, Yulin No.1 Hospital, Yulin No.2 Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View Citation

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 lo — View Citation

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 i — View Citation

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. — View Citation

Castillo J, Leira R, García MM, Serena J, Blanco M, Dávalos 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. Epub 2004 Jan 15. — View Citation

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 bl — View Citation

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. — View Citation

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: 10.10 — View Citation

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. — View Citation

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 — View Citation

Sandset EC, Bath PM, Boysen G, Jatuzis D, Kõrv J, Lüders S, Murray GD, Richter PS, Roine RO, Terént 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. — View Citation

Schrader J, Lüders S, Kulschewski A, Berger J, Zidek W, Treib J, Einhäupl 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 Survivor — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 3 months after onset
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