Acute StrokePhase 2PassNCT01603667
PG2 Injection 500 mg in Acute Stroke Study (Pass)
A Phase 2 study testing PG2 in people with Acute Stroke, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- PG2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to Oct 2015
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with acute ischaemic stroke
- Patient, or a family member with legally authorized responsibility, has given informed consent
- Age ≥20 years
- Infusion of study medication can be started within 3-6 hrs of stroke onset.
- NIHSS score of ≥ 7 - 24
Who cannot join
- Intracranial haemorrhage (ICH) identified by CT or MRI
- 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
- Pre-stroke mRS score of ≥ 2 (indicating previous disability)
- Known allergy to Astragalus membranaceus or its mayor derivatives (polysaccharides)
- Patients who are eligible for tPA treatment and has been treated with tPA.
- Participation in any investigational study in the previous 30 days
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- Any terminal illness such that patient would not be expected to survive more than 1 year
- 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
- Pregnant women (clinically evident)
- Previous stroke within last three months
- Past history or clinical presentation of ICH, arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
- Current use of oral anticoagulants with prolonged prothrombin time (INR > 1.6)
- 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
- Clinically significant hypoglycaemia (blood sugar < 50mg/dl)
- 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
- Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PG2 Injection 500 mg in Acute Stroke Study (Pass): A Randomized, Double-Blind, Placebo-Controlled Study of PG2 Injection 500 mg in Patients With Treatment Started Within 3-6 Hrs of the Onset of Acute Ischemic Stroke
The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.
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
Read the detailed description
Randomized, double-blind, placebo-controlled multi-center study of intravenous (IV) PG2 Injection 500 mg starting within 3-6 hrs of the onset of acute ischemic stroke
- Conditions
- Acute Stroke
- Being tested
- PG2, placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG2Drug
Also called Polysaccharides of Astragalus membranaceus
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
placeboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| PG2 Injection 500 mg | Experimental | PG2 Injection 500 mg Receives: Drug: PG2 |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2
Measured: 90 days
Secondary outcomes (1)
Percentage of patients who achieve a Day 90 BI score of 95-100 Percentage of patients who are free of recurrent stroke, cardiovascular events and death of all causes. Percentage of patients who are free of adverse events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Tri-Service General Hospital (TSGH), Changhua Christian Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University, En Chu Kong Hospital, Kuang Tien General Hospital, Chung Shan Medical University, Taipei Veterans General Hospital, Taiwan, Kaohsiung Veterans General Hospital., Taipei Medical University Shuang Ho Hospital, Cheng Hsin Rehabilitation Medical Center, Taipei Medical University WanFang Hospital
- Responsible party
- Sponsor
- Investigators
- Chung Y. Hsu, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603667
- Sponsor's protocol ID
- DMR100-IRB-185
- Acronym
- Pass
- Status last verified
- Nov 2016
- First submitted
- 20 May 2012
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PG2 Injection 500 mg in Acute Stroke Study (Pass): A Randomized, Double-Blind, Placebo-Controlled Study of PG2 Injection 500 mg in Patients With Treatment Started Within 3-6 Hrs of the Onset of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01603667
- Acronym / sponsor ID
- Pass / DMR100-IRB-185
- Conditions
- Acute Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Tri-Service General Hospital (TSGH), Changhua Christian Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University, En Chu Kong Hospital, Kuang Tien General Hospital, Chung Shan Medical University, Taipei Veterans General Hospital, Taiwan, Kaohsiung Veterans General Hospital., Taipei Medical University Shuang Ho Hospital, Cheng Hsin Rehabilitation Medical Center, Taipei Medical University WanFang Hospital
- Study start
- Jun 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 May 2012 (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 primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.
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
Randomized, double-blind, placebo-controlled multi-center study of intravenous (IV) PG2 Injection 500 mg starting within 3-6 hrs of the onset of acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG2 Injection 500 mg | Experimental | Drug: PG2PG2 Injection 500 mg |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with acute ischaemic stroke
- Patient, or a family member with legally authorized responsibility, has given informed consent
- Age ≥20 years
- Infusion of study medication can be started within 3-6 hrs of stroke onset.
- NIHSS score of ≥ 7 - 24
Key exclusion criteria (16 listed)
- Intracranial haemorrhage (ICH) identified by CT or MRI
- 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
- Pre-stroke mRS score of ≥ 2 (indicating previous disability)
- Known allergy to Astragalus membranaceus or its mayor derivatives (polysaccharides)
- Patients who are eligible for tPA treatment and has been treated with tPA.
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 |
|---|---|---|
| PG2Also: Polysaccharides of Astragalus membranaceusSTUDY 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 | Drug | PG2 Injection 500 mg |
| placeboSTUDY 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 | Drug | Placebo |
Primary outcome
The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2
Time frame: 90 days
1 secondary outcome
Percentage of patients who achieve a Day 90 BI score of 95-100 Percentage of patients who are free of recurrent stroke, cardiovascular events and death of all causes. Percentage of patients who are free of adverse events
Time frame: 90 days
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 4 Nov 2016.
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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.
Chung Y. Hsu, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG2 in people with Acute Stroke, run by China Medical University Hospital at 1 site in Taiwan.
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 16 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 4 Nov 2016. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2016.