Ginkgo Diterpene Lactone Meglumine Injection on Platelet Reactivity in

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03219645
Study type	Interventional
Source	RenJi Hospital
Contact
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	July 15, 2017
Completion date	December 31, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms