Clinical trial NCT03219645: Ginkgo Diterpene Lactone Meglumine Injection on Platelet Reactivity in Acute Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ischemic Stroke
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Kanion Pharmaceutical Co., Ltd
First posted: 2017-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent;
2. Female or male with 18 years ≤age ≤ 80 years;
3. Within 72 hours symptom onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
4. Modified Rankin Scale Score ≤2 at the time of randomization;
5. NIHSS \<12 points at the time of randomization;
6. Diagnosis of collaterals abstraction by phlegm and blood stasis in Traditional Chinese Medicine.

Exclusion Criteria:

1. Diagnosis of infection, cancer, autoimmune diseases,severe renal or hepatic insufficiency or deep vein thrombosis,etc;
2. Current treatment (last dose given within 10 days before randomization) with anticoagulation therapy or anti-platelet therapy;
3. Presumed cardiac source of embolus, e.g., atrial fibrillation, known prosthetic cardiac valves, suspected endocarditis or other cardioembolic pathology for stroke;
4. Low or high platelet count (\<100 x10\^9/L or \>300 x10\^9/L);
5. Clear indication for anticoagulation or thrombolysis;
6. Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
7. Blood pressure elevated(systolic \> 220mmHg or diastolic \>120mmHg);
8. Pregnancy or lactation, and women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test;
9. Known allergic to acetylsalicylic acid or Ginkgo Diterpene Lactone Meglumine;
10. With hemorrhagic disease or have a bleeding tendency;
11. Clear indication for Dual Antiplatelet Therapy with acetylsalicylic acid and clopidogrel;
12. Have to be fed through a nasal feeding tube;
13. Contraindication to acetylsalicylic acid;
14. Presumed probably poor adherence, or any other inappropriate conditions for patients to participate in this study.

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