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Effects of butylphthalide on reperfusion, collateral circulation and clinical prognosis in patients with acute ischemic stroke

Effects of butylphthalide on perfusion, collateral circulation and clinical prognosis in patients with acute ischemic stroke

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038241
Enrollment
Unknown
Registered
2020-09-15
Start date
2020-09-25
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Acute Ischemic Stroke

Interventions

butylphthalide in thrombolytic patients:Injection of butylphthalide for 7 days followed by taking butylphthalide capsules for 14 days in thromblytic patients
Non-butylphthalide in thrombolytic patients:Conventional treatment without butylphthalide in thromblytic patients
butylphthalide in non-thrombolytic patients:Injection of butylphthalide for 7 days followed by taking butylphthalide capsules for 14 days in non-thromblytic patients
Non-butylphthalide in non-thrombolytic patients:Conventional treatment without butylphthalide in non-thromblytic patients

Sponsors

Department of Neurology, Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient's age is >= 18 years; 2. Patients presenting with anterior circulation acute ischemic stroke with neurology impairment, and time from onset to enrollment is less than 24h; 3. First stroke or Pre-stroke mRS score of 1.2, penumbra volume < 70ml; 6. Informed consent was obtained from patients; 7. Butylphthalide have to be started in the treatment group within 2 hours after randomization.

Exclusion criteria

Exclusion criteria: 1. The patients with intracranial hemorrhagic diseases seen by CT; 2. Patients with posterior circulation cerebral infarction; 3. Patients with bleeding prone diseases; 4. Patients with liver and kidney dysfunction; 5. Patients complicated with malignant tumor or undergoing anti-tumor therapy; 6. Patients with allergic constitution are allergic to celery and butylphthalide; 7. Patients with heart failure and multiple system failure; 8. Pregnant or lactating women; 9. Patients with dementia or mental problems who cannot cooperate with follow-up; 10. Patients with claustrophobia and metal implants who cannot be examined by cranial MRI; 11. Patients who plan to take thrombus by pulse; 12. Patients who have participated in other clinical trials now or in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Improvement of reperfusion volume in acute cerebral infarction;Increased infarct core volume;Proportion of symptomatic hemorrhagic transformation;

Secondary

MeasureTime frame
Proportion of patients with mRS score =2;NIHSS score improvement rate at day 90;mortality in day 90;

Countries

China

Contacts

Public ContactXueyuan Liu

The Tenth Affiliated People's Hospital of Tongji University

xyliu@tongji.edu.cn+86 13564578127

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026