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

Acute Ischemic Stroke Clinical Trial

— PAIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966316
• Other study ID #: 200707004
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: May 14, 2011
• Start date: May 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• aspirin,chinese herbs;
aspirin 300mg/100mg,qd,chinese herbs, one dose ,qd

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & 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 Coun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death rate;average hospital day;cost of hospitalization		3 months;discharge day	No
Secondary	Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction		7 day;30 day;3 months	No

External Links

•   Link