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PG2 Injection 500 mg in Acute Stroke Study (Pass) (Pass)

Primary Purpose

Acute Stroke

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

PG2

placebo

About this trial

This is an interventional treatment trial for Acute Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PG2 Injection 500 mg

Placebo

Arm Description

PG2 Injection 500 mg

Placebo

Outcomes

Primary Outcome Measures

The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01603667

First Posted

May 20, 2012

Last Updated

November 3, 2016

Sponsor

China Medical University Hospital

Collaborators

National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Tri-Service General Hospital, 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

1. Study Identification

Unique Protocol Identification Number

NCT01603667

Brief Title

PG2 Injection 500 mg in Acute Stroke Study (Pass)

Acronym

Pass

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Medical University Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PG2 Injection 500 mg

Arm Type

Experimental

Arm Description

PG2 Injection 500 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

PG2

Other Intervention Name(s)

Polysaccharides of Astragalus membranaceus

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chung Y. Hsu, PhD

Organizational Affiliation

China Medical University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

12. IPD Sharing Statement

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