Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2012-06-30
2015-10-31
Brief Summary
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The secondary objectives are as follows:
* To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
* To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
* To evaluate the safety of PG2 Injection 500 mg treatment
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PG2 Injection 500 mg
PG2 Injection 500 mg
PG2
STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days.
ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days
Placebo
Placebo
placebo
STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days.
ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days
Interventions
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PG2
STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days.
ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days
placebo
STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days.
ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient, or a family member with legally authorized responsibility, has given informed consent
3. Age ≥20 years
4. Infusion of study medication can be started within 3-6 hrs of stroke onset.
5. NIHSS score of ≥ 7 - 24
Exclusion Criteria
2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \< 6 at randomization
3. Pre-stroke mRS score of ≥ 2 (indicating previous disability)
4. Known allergy to Astragalus membranaceus or its mayor derivatives (polysaccharides)
5. Patients who are eligible for tPA treatment and has been treated with tPA.
6. Participation in any investigational study in the previous 30 days
7. Any terminal illness such that patient would not be expected to survive more than 1 year
8. Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as haemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the Investigator
9. Pregnant women (clinically evident)
10. Previous stroke within last three months
11. Past history or clinical presentation of ICH, arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
12. Current use of oral anticoagulants with prolonged prothrombin time (INR \> 1.6)
13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hrs and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range
14. Clinically significant hypoglycaemia (blood sugar \< 50mg/dl)
15. Uncontrolled hypertension defined by a blood pressure \> 185 mmHg systolic or \>110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator
16. Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Shin Kong Wu Ho-Su Memorial Hospital
OTHER
Tri-Service General Hospital
OTHER
Changhua Christian Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Kaohsiung Medical University
OTHER
En Chu Kong Hospital
OTHER
Kuang Tien General Hospital
OTHER
Chung Shan Medical University
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Kaohsiung Veterans General Hospital.
OTHER
Taipei Medical University Shuang Ho Hospital
OTHER
Cheng Hsin Rehabilitation Medical Center
OTHER
Taipei Medical University WanFang Hospital
OTHER
China Medical University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chung Y. Hsu, PhD
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, Taiwan, Taiwan
Countries
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Other Identifiers
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DMR100-IRB-185
Identifier Type: -
Identifier Source: org_study_id