Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke (PAIS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke	Drug: aspirin，chinese herbs；	Phase 4

Detailed Description:

Eligibility Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Those clinically diagnosed with acute ischemic stroke ； 18-85 years old； Over 6 hours and within 14 days from onset 4<=NIHSS <=22; Informed consent signed by patient or his/her family ；

Exclusion Criteria:

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

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	314 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke
Study Start Date :	May 2009
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	January 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: pathway; aspirin，Chinese herbs；acupuncture；rehabilitation；health education；	Drug: aspirin，chinese herbs； aspirin 300mg/100mg,qd,chinese herbs, one dose ，qd; Other Name: Bayer

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. death rate；average hospital day；cost of hospitalization [ Time Frame: 3 months；discharge day ]

Secondary Outcome Measures :

1. Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction [ Time Frame: 7 day；30 day；3 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Ischemic stroke diagnosed with both criteria of traditional Chinese medicine and western medicine；
• 18-85 years old；
• Over 6 hours and within 14 days from onset
• 4<=NIHSS <=22;
• Informed consent signed by patient or his/her family ；

Exclusion Criteria:

• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120

Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine

Investigators

Study Chair:	yefeng cai, postgraduate	Guangdong Provincial Hospital of Traditional Chinese Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Publications of Results:

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. Erratum in: Circulation. 2007 Oct 30;116(18):e515.

Responsible Party:	Yefeng,Cai, Guangdong Provincial Hospital of Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00966316 History of Changes
Other Study ID Numbers:	200707004
First Posted:	August 26, 2009
Last Update Posted:	May 17, 2011
Last Verified:	May 2011

Keywords provided by Guangzhou University of Traditional Chinese Medicine:

Acute Ischemic Stroke；clinical pathway;TCM；

Additional relevant MeSH terms:

Stroke; Ischemia; Cerebral Infarction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Aspirin; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics