CHInese Medicine NeuroAid Efficacy on Stroke Recovery (CHIMES)

CHIMES Society

Status and phase

Completed

Phase 3

Conditions

Cerebral Infarction

Stroke

Treatments

Drug: NeuroAid

Drug: NeuroAid matched Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00554723

SQSTR03 - CHIMES

Details and patient eligibility

About

CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.

Full description

Stroke is a major cause of death and disability. Previous clinical studies performed in China have shown that NeuroAiD increase stroke patients'recovery in terms of neurological disability and functional outcome{Chen et al,2009}and thus may be beneficial as part of a post-stroke rehabilitation programme.

In the CHIMES study,we seek to test the hypothesis that NeuroAiD is superior to a placebo in reducing neurological deficit and improving functional outcome in patients recruited within 72 h after the ischemic stroke with intermediate range of severity {6<_NIHSS<_14}.More details of the study protocol have recently been published {Venketasubramanian et al,2009}.

Enrollment

1,100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is aged 18 years old and above (for Singapore 21 years and above as this is the legal age of consent)
Subject is on anti-platelet therapy
Subject is presented a pre-stroke Modified Rankin Scale inferior or equal to 1
Female subject is eligible to participate in the trial if she is of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post menopausal)
Subject or his/her legally acceptable representative is willing to provide written informed consent
Subject is presented with cerebral infarction with compatible imaging at Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
Time window is less than 72 hours after symptoms onset
Subject with cerebral infarction with intermediate severity range: 6 ≤ NIHSS ≤ 14

Exclusion criteria

Subjects deemed unstable by investigator after thrombolysis treatment
Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
Subject has a rapidly improving neurological deficit
Subject has definite indication for full-dose or long-term anticoagulation therapy
Subject has other significant non-ischemic brain lesion which could affect function disability
Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine > 200 μmol/L, if known), cirrhosis, severe dementia or psychosis
Subject has participated in another clinical trial within the last three months