Ginkgo Diterpene Lactone Meglumine Injection on Platelet Reactivity in Acute Ischemic Stroke "GDPRS"

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(300mg loading dose,then 100mg once/day D2-D14) in combination, while the other half will receive aspirin(300mg loading dose,then 100mg once/day D2-D14).

Detailed Description

The GDPRS trial is a prospective, randomized, single-centre, open-label, active-controlled, blinded-endpoint trial (a PROBE design concerning clinical trial). A total of approximately 40 patients (18 years≤Age≤ 80 years) with acute ischemic stroke (NIHSS < 12), who can be treated within 72 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14(the injection must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 hours), combined with Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14. 2) the other group will receive a 300 mg loading dose of Aspirin on the day of randomization, followed by Aspirin 100 mg once/day from Day 2 to Day 14. The primary objective is to assess the anti-platelet effects of Ginkgo Diterpene Lactone Meglumine Injection combined with Aspirin versus Aspirin alone in patients with acute ischemic stroke. The study consists of 4 visits including the day of randomization, 24 hours after the first anti-platelet agents,Day 14±2days and Day 90±7days. The antiplatelet effects will be analyzed in total subjects. The trial is anticipated to complete in 6 months from the first subject recruitment , with 40 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Renji hospital,Shanghai Jiaotong University School of Medicine.

Conditions

Interventions

  • Acetylsalicylic acid Drug
    Other Names: Aspirin 81 mg
    Intervention Desc: Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.
    ARM 1: Kind: Experimental
    Label: Ginkgo and aspirin
    Description: Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours;combined with Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.
    ARM 2: Kind: Experimental
    Label: aspirin
    Description: Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.
  • Ginkgo diterpene lactone meglumine injection Drug
    Other Names: YinxingErtieneizhiPu'an Zhusheye
    Intervention Desc: The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours.
    ARM 1: Kind: Experimental
    Label: Ginkgo and aspirin
    Description: Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours;combined with Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.

Outcomes

Type Measure Time Frame Safety Issue
Primary ARU on day 14 14 days
Secondary PL-12 AA at 24 hours and day 14 24 hours,14 days
Secondary PL-12 ADP at 24 hours and day 14 24 hours,14 days
Secondary PL-12 PAF at 24 hours and day 14 24 hours,14 days
Secondary PL-12 Coll at 24 hours and day 14 24hours,14 days
Secondary PL-12 Adr at 24 hours and day 14 24 hours,14 days
Secondary TEG-AA on day 14 14 days
Secondary TEG-ADP on day 14 14 days
Secondary ARU at 24 hours 24 hours
Secondary AA HOPR VerifyNow® 24 hours,14 days
Secondary Aspirinworks 24 hours,14days
Secondary Impairment 14 days,90days
Secondary Modified Rankin Scale score changes 14 days,90 days
Secondary New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage). 14 days
Secondary New composite clinical vascular events (ischemic stroke/ hemorrhagic stroke/TIA/ myocardial infarction/ vascular death) as a cluster. 14days,90 days
Secondary Major bleed (PLATO definition), including fatal/life-threatening and other. 14days,90 days
Secondary Intracranial hemorrhagic events. 14days,90 days
Secondary Total mortality. 14days,90 days

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