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

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

Study Overview

• Status: Completed
• Conditions: Acute Stroke
• Intervention / Treatment: Drug: PG2; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients presenting with acute ischaemic stroke
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:

1. Intracranial haemorrhage (ICH) identified by CT or MRI
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: 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
EXPERIMENTAL: PG2 Injection 500 mg	Drug: 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; Other Names: Polysaccharides of Astragalus membranaceus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	90 days

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: National Taiwan University Hospital; Shin Kong Wu Ho-Su Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National Cheng-Kung University Hospital; Taipei Medical University Shuang Ho Hospital; Taipei Medical University WanFang Hospital; Kaohsiung Medical University; Tri-Service General Hospital; Changhua Christian Hospital; Kaohsiung Veterans General Hospital.; Kuang Tien General Hospital; Chung Shan Medical University; En Chu Kong Hospital; Cheng Hsin Rehabilitation Medical Center
• Investigators: Principal Investigator: Chung Y. Hsu, PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: May 20, 2012
• First Submitted That Met QC Criteria: May 20, 2012
• First Posted (ESTIMATE): May 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DMR100-IRB-185