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| Name | Class |
|---|---|
| Jiangsu Kanion Pharmaceutical Co., Ltd | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgo and aspirin | Active Comparator | 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. |
|
| aspirin | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginkgo Diterpene Lactone Meglumine Injection | Drug | The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| ARU on day 14 | Residual Platelet Reactivity defined as the value of Aspirin Reaction Unit (ARU) measured by VerifyNow® assay on day 14. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| PL-12 AA at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid. | 24 hours,14 days |
| PL-12 ADP at 24 hours and day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| Acetylsalicylic acid | Drug | 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. |
|
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Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate.
| 24 hours,14 days |
| PL-12 PAF at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of PAF(Platelet activating factor). | 24 hours,14 days |
| PL-12 Coll at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®) using the inducer of collegen. | 24hours,14 days |
| PL-12 Adr at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®) using the inducer of adrenaline. | 24 hours,14 days |
| TEG-AA on day 14 | Residual platelet reactivity defined as the value of Maximum Amplitude- acetylsalicylic acid (MA-AA) measured by Thrombelastography Platelet Mapping Assay (TEG) using the inducer of acetylsalicylic acid. | 14 days |
| TEG-ADP on day 14 | Residual platelet reactivity defined as the value of Maximum Amplitude- adenosine diphosphate (MA-AA) measured by Thrombelastography Platelet Mapping Assay (TEG) using the inducer of adenosine diphosphate | 14 days |
| ARU at 24 hours | Residual platelet reactivity defined as the value of Aspirin reaction unit (ARU) measured by VerifyNow® assay at 24 hours. | 24 hours |
| AA HOPR VerifyNow® | High on-treatment platelet reactivity defined as Aspirin reactivity unit (ARU)> 555 measured by VerifyNow® assay. | 24 hours,14 days |
| Aspirinworks | Residual platelet reactivity detected by AspirinWorks. | 24 hours,14days |
| Impairment | Changes in NIHSS and mRS at 14 days and 90 days. | 14 days,90days |
| Modified Rankin Scale score changes | Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 | 14 days,90 days |
| New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage). | All the new vascular events will be assessed by at least two neurologists based on neuroimaging and clinical feature. When there was disagreement, a third senior neurologist was consulted to reach a consensus decision. | 14 days |
| New composite clinical vascular events (ischemic stroke/ hemorrhagic stroke/TIA/ myocardial infarction/ vascular death) as a cluster. | The PLATO(Platelet Inhibition and Patient Outcomes) definition of fatal/life-threatening of major bleed is any one of the following: Fatal, Intracranial, Intrapericardial bleed with cardiac tamponade, Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery, Clinically overt or apparent bleeding associated with a decrease in hemoglobin(Hb) of more than50 g/L, Transfusion of 4 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding. The PLATO definition of other of major bleed is any one of the following:Significantly disabling (eg. intraocular with permanent vision loss), Clinically overt or apparent bleeding associated with a decrease in Hb of 30 g/L to 50 g/L, Transfusion of 2-3 units (whole blood or PRBCs) for bleeding. | 14days,90 days |
| Major bleed (PLATO definition), including fatal/life-threatening and other. | The PLATO(Platelet Inhibition and Patient Outcomes) definition of fatal/life-threatening of major bleed is any one of the following: Fatal, Intracranial, Intrapericardial bleed with cardiac tamponade, Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery, Clinically overt or apparent bleeding associated with a decrease in hemoglobin(Hb) of more than50 g/L, Transfusion of 4 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding. The PLATO definition of other of major bleed is any one of the following:Significantly disabling (eg. intraocular with permanent vision loss), Clinically overt or apparent bleeding associated with a decrease in Hb of 30 g/L to 50 g/L, Transfusion of 2-3 units (whole blood or PRBCs) for bleeding. | 14days,90 days |
| Intracranial hemorrhagic events. | Intracranial hemorrhagic events is assessed by brain computed tomography (CT) or gradient recalled echo (GRE) T2 star weighted MRI. | 14days,90 days |
| Total mortality. | All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular. | 14days,90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |