Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke (PAIS)
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ClinicalTrials.gov Identifier: NCT00966316 |
Recruitment Status
:
Completed
First Posted
: August 26, 2009
Last Update Posted
: May 17, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Drug: aspirin,chinese herbs; | Phase 4 |
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 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 |

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
|
- death rate;average hospital day;cost of hospitalization [ Time Frame: 3 months;discharge day ]
- Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction [ Time Frame: 7 day;30 day;3 months ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966316
China, Guangdong | |
Guangdong Provincial Hospital of Chinese Medicine | |
Guangzhou, Guangdong, China, 510120 |
Study Chair: | yefeng cai, postgraduate | Guangdong Provincial Hospital of Traditional Chinese Medicine |
Additional Information:
Publications of Results:
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 Key Record Dates |
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 |