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The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2)
Delcourt, C.1; Huang, Y.2; Wang, J.3; Heeley, E.1; Lindley, R.4; Stapf, C.5,6; Tzourio, C.6; Arima, H.1; Parsons, M.7; Sun, J.8; Neal, B.1; Chalmers, J.1; Anderson, C.1; INTERACT2 Investigators
关键词blood pressure clinical trial hypertension INTERACT intracerebral haemorrhage stroke
刊名INTERNATIONAL JOURNAL OF STROKE
2010-04-01
5期:2页:110-116
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Peripheral Vascular Disease
研究领域[WOS]Cardiovascular System & Cardiology
关键词[WOS]SPONTANEOUS INTRACEREBRAL HEMORRHAGE ; ACUTE STROKE ; CONSERVATIVE TREATMENT ; CLINICAL-TRIAL ; CHINA ; PREVALENCE ; MANAGEMENT ; SUBTYPES ; SCALE
英文摘要

Rationale

The INTERACT pilot study demonstrated the feasibility of the protocol, safety of early intensive blood pressure lowering and effects on haematoma expansion within 6 h of onset of intracerebral haemorrhage. This article describes the design of the second, main phase, INTERACT2.

Aims

To compare the effects of a management strategy of early intensive blood pressure lowering with a more conservative guideline-based blood pressure management policy in patients with acute intracerebral hemorrhage.

Design

INTERACT2 is a prospective, randomized, open label, assessor-blinded end-point (PROBE). Patients with a systolic blood pressure greater than 150 mmHg and no definite indication for or contraindication to blood pressure-lowering treatment are centrally randomised to either of two treatment groups within 6 h onset of intracerebral haemorrhage. Those allocated to intensive blood pressure lowering will receive primarily intravenous, hypotensive agents to achieve a systolic blood pressure target of < 140 mmHg within 1 h of randomisation and to maintain this level for up to 7 days in hospital. The control group will receive blood pressure-lowering treatment to a target systolic blood pressure of < 180 mmHg. Both groups are to receive similar acute stroke unit care, therapy and active management. Oral antihypertensive therapy is recommended in patients before hospital discharge with a long-term systolic blood pressure goal of 140 mmHg according to secondary stroke prevention guidelines. A projected 2800 subjects are to be enrolled from approximately 140 centres worldwide to provide 90% power (alpha 0 center dot 05) to detect a 14% difference in the risk of death and dependency between the groups, which equates to one or more cases of a poor outcome prevented in every 15 patients treated.

Study outcomes

The primary outcome is the combined end-point of death and dependency according to the modified Rankin Scale at 90 days. The secondary outcomes are the separate components of the primary end-point in patients treated < 4 hours of ICH onset, grades of physical function on the modified Rankin Scale, health-related quality of life on the EuroQoL, recurrent stroke and other vascular events, days of hospitalisation, requirement for permanent residential care and unexpected serious adverse events. The study is registered under NCT00716079, ISRCTN73916115 and ACTRN12608000362392.

语种英语
WOS记录号WOS:000275336500010
项目编号512402 ; 571281
资助机构National Health and Medical Research Council (NHMRC) of Australia
引用统计
被引频次:81[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/67600
专题北京大学第一临床医学院_神经内科
作者单位1.Univ Sydney, Royal Prince Alfred Hosp, George Inst Int Hlth, Sydney, NSW 2050, Australia
2.Peking Univ, Hosp 1, Dept Neurol, Beijing 100871, Peoples R China
3.Shanghai Jiao Tong Univ, Rui Jin Hosp, Shanghai Inst Hypertens, Shanghai 200030, Peoples R China
4.Univ Sydney, Sydney Med Sch Western, Sydney, NSW 2050, Australia
5.Lariboisiere Hosp, APHP, Clin Res Unit, European Reg Coordinating Ctr,Dept Neurol, Paris, France
6.APHP, INSERM, Unit 708, Paris, France
7.Univ Newcastle, Hunter Med Res Inst, John Hunter Hosp, New Lambton, NSW, Australia
8.George Inst, Beijing, Peoples R China
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GB/T 7714
Delcourt, C.,Huang, Y.,Wang, J.,et al. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2)[J]. INTERNATIONAL JOURNAL OF STROKE,2010,5(2):110-116.
APA Delcourt, C..,Huang, Y..,Wang, J..,Heeley, E..,Lindley, R..,...&INTERACT2 Investigators.(2010).The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2).INTERNATIONAL JOURNAL OF STROKE,5(2),110-116.
MLA Delcourt, C.,et al."The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2)".INTERNATIONAL JOURNAL OF STROKE 5.2(2010):110-116.
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