Acute Ischemic StrokePhase 4PAISNCT00966316
Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke
A Phase 4 study testing aspirin，chinese herbs； in people with Acute Ischemic Stroke, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- aspirin，chinese herbs；
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ；
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
About this study
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
Read the 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
- Conditions
- Acute Ischemic Stroke
- Being tested
- aspirin，chinese herbs；
- Keywords
- Acute Ischemic Stroke；clinical pathway;TCM；
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin，chinese herbs；Drug
Also called Bayer
aspirin 300mg/100mg,qd,chinese herbs, one dose ，qd
| Study group | Role | What they receive |
|---|---|---|
| pathway | Experimental | aspirin，Chinese herbs；acupuncture；rehabilitation；health education； Receives: Drug: aspirin，chinese herbs； |
What is being measured
The primary outcome is the main question the study is designed to answer.
death rate；average hospital day；cost of hospitalization
Measured: 3 months；discharge day
Secondary outcomes (1)
Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction
Measured: 7 day；30 day；3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- yefeng cai, postgraduate, Study chair, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966316
- Sponsor's protocol ID
- 200707004
- Acronym
- PAIS
- Status last verified
- May 2011
- First submitted
- 25 Aug 2009
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17515473
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00966316
- Acronym / sponsor ID
- PAIS / 200707004
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke；clinical pathway;TCM；
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pathway | Experimental | Drug: aspirin，chinese herbs；aspirin，Chinese herbs；acupuncture；rehabilitation；health education； |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 ；
Key exclusion criteria (6 listed)
- Hemorrhagic stroke;
- Cerebral hernia;
- Serious heart, liver, lung, kidney functional failure,malignancy;
- Not cooperative with physician;
- Psychological disorder;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin，chinese herbs；Also: Bayeraspirin 300mg/100mg,qd,chinese herbs, one dose ，qd | Drug | pathway |
Primary outcome
death rate；average hospital day；cost of hospitalization
Time frame: 3 months；discharge day
1 secondary outcome
Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction
Time frame: 7 day；30 day；3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Results publication: PubMed 17515473Adams 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yefeng cai, postgraduate study chair
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin，chinese herbs； in people with Acute Ischemic Stroke, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death rate；average hospital day；cost of hospitalization (time frame: 3 months；discharge day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.