NCT00966316

Brief Summary

The purpose of this study is to determine whether the clinical pathway for acute ischemic stroke(with combination of traditional Chinese medicine and western medicine) is able to improve the outcome of acute ischemic stroke and evaluate its effect on hospital day and cost, etc. Meanwhile, the study will discuss the safety and efficiency of this kind of Clinical Pathway

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

August 25, 2009

Last Update Submit

May 14, 2011

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke；clinical pathway;TCM；

Outcome Measures

Primary Outcomes (1)

  • death rate；average hospital day；cost of hospitalization

    3 months；discharge day

Secondary Outcomes (1)

  • Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction

    7 day；30 day；3 months

Study Arms (1)

pathway

EXPERIMENTAL

aspirin，Chinese herbs；acupuncture；rehabilitation；health education；

Drug: aspirin，chinese herbs；

Interventions

aspirin，chinese herbs；DRUG

aspirin 300mg/100mg,qd,chinese herbs, one dose ，qd

Also known as: Bayer
pathway

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke diagnosed with both criteria of traditional Chinese medicine and western medicine；
  • years old；
  • Over 6 hours and within 14 days from onset
  • \<=NIHSS \<=22;
  • Informed consent signed by patient or his/her family ；

You may not qualify if:

  • Hemorrhagic stroke;
  • Cerebral hernia;
  • Serious heart, liver, lung, kidney functional failure,malignancy;
  • Not cooperative with physician;
  • Psychological disorder;
  • Already taken part in other clinical drug trial within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

  • Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association/American Stroke Association Stroke Council; American Heart Association/American Stroke Association Clinical Cardiology Council; American Heart Association/American Stroke Association Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease Working Group; Quality of Care Outcomes in Research Interdisciplinary Working Group. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007 May 22;115(20):e478-534. doi: 10.1161/CIRCULATIONAHA.107.181486.

    PMID: 17515473RESULT

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • yefeng cai, postgraduate

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2010

Study Completion

January 1, 2011

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

CN(1)