NCT03219645

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

A Randomized, Active-Controlled，Blinded-Endpoint and Parallel Group Pilot Trial Comparing the Antiplatelet Effects of Ginkgo Diterpene Lactone Meglumine Injection Plus Aspirin Versus Aspirin Alone in Patients With Acute Ischemic Stroke

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Ginkgo Diterpene Lactone Meglumine Injection	The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours.
DRUG	Acetylsalicylic acid	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.

Timeline

• Start date: 2017-07-15
• Primary completion: 2017-10-31
• Completion: 2017-12-31
• First posted: 2017-07-17
• Last updated: 2017-07-17