Hypertension Clinical Trial
— CHASEOfficial title:
A Multi-center Randomised Controlled Trial to Explore the Ideal Individualized Anti-hypertension Strategies in Patients With Severe Stroke at Acute Stage
Verified date | September 2018 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this academic lead study is to explore ideal blood pressure targets and optimum individualized anti-hypertension strategies in acute severe stroke.
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. |
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 |
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 |
China,
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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
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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
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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