Page 33

Karger_ESC London_2013

London, United Kingdom 2013 3 Large clinical trials (RCTs) A 11:55 - 12:10 DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED, MULTICENTER STUDY TO INVESTIGATE CHINESE MEDICINE NEUROAID EFFICACY ON STROKE RECOVERY (CHIMES) C. Chen1 CHIMES Investigators National University of Singapore, Singapore, SINGAPORE1 Background and aims : Meta-analyses of Traditional Chinese Medications (TCM) in stroke have concluded that the evidence for efficacy and safety is scanty due to a lack of well designed randomized placebo controlled clinical trials Wu et al, 2007; Zhang et al, 2009. NeuroAiD is a TCM which has been shown to restore neurological and cellular function in animal models of stroke by repair processes (Heurteaux, 2010). Previous clinical studies on patients 2 weeks to 6 months after index stroke have shown that NeuroAiD increases recovery in terms of neurologi-cal disability and functional outcome Chen et al, 2009 and may be beneficial as part of a post-stroke rehabilitation programme. In the CHIMES study, the hypothesis that NeuroAiD is su-perior to placebo in reducing neurological deficit and improving functional outcome within 72 hours of acute ischemic stroke in patients with cerebral infarction of intermediate severity (6 ≤ NIHSS ≤ 14) is investigated. Methods : Details of the study protocol have been published Ven-ketasubramanian et al, 2009. Results : CHIMES recruited its target of 1100 patients in June 2012 and database lock was accomplished in January 2013. It involved sites in the Philippines, Singapore, Thailand, Sri Lanka, Hong Kong and Malaysia. Safety data for additional laboratory tests was conducted in Singapore sites at the request of the Singapore regulators. These results were analysed with the investigators and steering committee remaining blinded to the treatment allocation Young et al, 2010 and showed no safety concerns. The planned primary and sec-ondary analyses will be reported. Conclusions : CHIMES is the largest trial investigating the efficacy of a TCM on stroke recovery after acute stroke, performed in compliance with interna-tional guidelines and using Western clinical trial standards. It would therefore be a significant contribution to the evidence base for the efficacy and safety of TCM in stroke. Cerebrovasc Dis 2013; 35 (suppl 3)1-854 33 2 Large clinical trials (RCTs) A 11:40 - 11:55 The Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II): Results A.D. Mendelow1, B.A. Gregson2, E. Rowan3, P. Mitchell4, A. Gholkar5, G. Murray6 STICH II Investigators Newcastle University, Newcastle upon Tyne, UNITED KINGDOM1,Newcastle University, Newcastle upon Tyne, UNITED KINGDOM2, Newcastle University, Newcastle upon Tyne, UNITED KINGDOM3, Newcastle University, Newcastle upon Tyne, UNITED KINGDOM4, Newcastle University, , UNITED KINGDOM5, Edinburgh University, Edinburgh, UNITED KINGDOM6 Background The treatment of spontaneous supratentorial intracerebral haemorrhage (ICH) has been the sub-ject of controversy for over 50 years ever since McKissock published the first prospective ran-domised controlled trial of operation versus conservative treatment for ICH. That trial revealed a worse outcome for those patients who underwent surgery, initiating controversy over selec-tion of surgical candidates and utilization of surgery. Neurosurgeons recognise many situations where removal of haematomas appears to improve outcome: for example every neurosurgeon would evacuate a large postoperative haematoma following an elective craniotomy. Meta-anal-ysis of 14 trials of surgery for ICH suggests that early surgery has an advantage over initial conservative treatment and post hoc analysis of the first Surgical Trial in Intra Cerebral Haem-orrhage (STICH) suggested that lobar haematomas near the surface had a better outcome with craniotomy. Methods STICH II has completed the recruitment of 601 patients with superficial lobar haematomas of 10 to 100ml within 1cm of the cortex surface. Patients were randomised to early surgery (with-in 12 hours) or to initial conservative treatment. In STICH II a five day CT scan was obtained in each group, so it will be possible to evaluate the hypothesis that the volume of clot reduction is correlated with favourable outcome. The six month follow-up should be completed by the end of January 2013. Results The final results of STICH II will be presented to the public domain for the first time in this pa-per. Conclusions Even if a neutral result evolves, the relationship between initial ICH volume and five day vol-ume, as determined by the five day CT scan, will become clear and lend support, or otherwise, to other strategies that seek to minimise clot expansion or promote clot size reduction such as those being tested in the MISTIE and CLEAR Trials in which clot lysis is achieved with drain-age and topical tPA.


Karger_ESC London_2013
To see the actual publication please follow the link above