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

NCT03219645 | Unknown Phase 2 DMC

• 1 other identifier: 2016-194（3）
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• PL-12 AA at 24 hours and day 14

  24 hours,14 days

• PL-12 ADP at 24 hours and day 14

  24 hours,14 days

• PL-12 PAF at 24 hours and day 14

  24 hours,14 days

• PL-12 Coll at 24 hours and day 14

  24hours,14 days

• PL-12 Adr at 24 hours and day 14

  24 hours,14 days

Study Arms (2)

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.

Drug: Ginkgo Diterpene Lactone Meglumine Injection; Drug: Acetylsalicylic acid

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.

Drug: Acetylsalicylic acid

Interventions

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.

Also known as: YinxingErtieneizhiPu'an Zhusheye

Ginkgo and aspirin

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.

Also known as: Aspirin

Ginkgo and aspirin; aspirin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diagnosis of infection, cancer, autoimmune diseases,severe renal or hepatic insufficiency or deep vein thrombosis,etc;
• Current treatment (last dose given within 10 days before randomization) with anticoagulation therapy or anti-platelet therapy;
• Presumed cardiac source of embolus, e.g., atrial fibrillation, known prosthetic cardiac valves, suspected endocarditis or other cardioembolic pathology for stroke;
• Low or high platelet count (\<100 x10\^9/L or \>300 x10\^9/L);
• Clear indication for anticoagulation or thrombolysis;
• 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;
• Blood pressure elevated(systolic \> 220mmHg or diastolic \>120mmHg);
• Pregnancy or lactation, and women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test;
• Known allergic to acetylsalicylic acid or Ginkgo Diterpene Lactone Meglumine;
• With hemorrhagic disease or have a bleeding tendency;
• Clear indication for Dual Antiplatelet Therapy with acetylsalicylic acid and clopidogrel;
• Have to be fed through a nasal feeding tube;
• Contraindication to acetylsalicylic acid;
• Presumed probably poor adherence, or any other inappropriate conditions for patients to participate in this study.

Sponsors & Collaborators

• RenJi Hospital: lead
• Jiangsu Kanion Pharmaceutical Co., Ltd: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 17, 2017
• Study Start: July 15, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-05