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Ginkgolide in Ischmic Stroke patients with large Artery Atherosclerosis(GISAA)

The efficacy and safty of Ginkgolide in Ischmic Stroke patients with large Artery Atherosclerosis(GISAA)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012310
Enrollment
Unknown
Registered
2017-08-09
Start date
2016-07-01
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

ginkgolide:ginkgolide injection + oral aspirin
Control:oral aspirin

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with the diagnostic criteria for ischemic stroke; Diagnostic criteria: (1) Acute onse; (2) Focal neurological impairment (unilateral face or limb weakness or numbness, language, etc.); a small number have general neurological impairment; (3) Symptoms and signs last for hours or more; (4) Brain CT or MRI ruled out intracerebral hemorrhage and other lesions; (5) Brain CT or MRI showed a major infarction lesion; 2. MRA or CTA showed atherosclerotic cause carotid artery, anterior cerebral artery, middle cerebral artery, posterior cerebral artery or vertebrobasilar artery stenosis; 3. onset in 72h;3< NIHSS score=25; 4. First onset, or past onset, not associated with serious sequelae; 5. Voluntary consent of informed consent.

Exclusion criteria

Exclusion criteria: 1. Transient ischemic attack; 2. Patients who have been or are scheduled to be treated with thrombolysis; 3. Imaging showed patient with cerebral hemorrhage; 4. Patients with cerebral hemorrhage and cerebral arteritis after cerebral infarction; 5. Brain embolism caused by atrial fibrillation, brain tumor, brain trauma, brain parasitic disease, rheumatic heart disease, coronary heart disease and other heart diseases; 6 Liver dysfunction (ALT/AST=2×upper limit of normal [ULN]), renal dysfunction (Cr >1.5×ULN); 7. Bleeding tendency, severe bleeding occurred within 3 months, PLT ULN of more than 3 seconds; 8. Patients treated with double resistance; 9. Allergic to ginkgo, alcohol, glycerin; 10. Women during pregnancy and lactation period or plan to be pregnant; 11. Participants in other clinical studies for the last 1 months; 12. Other conditions making it inappropriate to participate in this clinical study in the investigators opinions.

Design outcomes

Primary

MeasureTime frame
the recurrence rate and mortality rate of ischemic stroke ;NIHSS scale;

Countries

China

Contacts

Public ContactQiang Dong

Huashan Hospital, Fudan University

dong_qiang@fudan.edu.cn+86 13701747065

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026