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学科主题: 临床医学
题名:
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)
作者: 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
发表日期: 2010-04-01
卷: 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
所属项目编号: 512402 ; 571281
项目资助者: National Health and Medical Research Council (NHMRC) of Australia
WOS记录号: WOS:000275336500010
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/67600
Appears in Collections:北京大学第一临床医学院_神经内科_期刊论文

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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

Recommended Citation:
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.
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