Controlling Hypertension After Severe Cerebrovascular Event

Hypertension Clinical Trial

— CHASE  

Official title:

A Multi-center Randomised Controlled Trial to Explore the Ideal Individualized Anti-hypertension Strategies in Patients With Severe Stroke at Acute Stage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982655
• Other study ID #: KY20162085-2
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acute Stroke
• Hypertension
• Severe Stroke
• Stroke

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 all — Click 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