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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394950
Other study ID # k201731
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 25, 2018
Est. completion date May 29, 2021

Study information

Verified date June 2021
Source General Hospital of Shenyang Military Region
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunctional prognosis of thrombolytic patients has been a hot topic in the world. Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate. Based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute ischemic stroke.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 29, 2021
Est. primary completion date May 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age >18 years; 2. Diagnosis of anterior circulation infarct; 3. First stroke onset or past stroke without obvious neurological deficit (mRS=1); 4. Time from onset to treatment =4.5 hours; 5. SBP/DBP = 180/110mmHg; 6. No hemorrhagic imaging changes showed in CT; 7. Signed informed consent by patient self or legally authorized representatives. Exclusion Criteria: 1. History of stroke within 3 months; 2. History of intracranial hemorrhage; 3. Suspected subarachnoid hemorrhage; 4. Intracranial tumour, vascular malformation or arterial aneurysm; 5. Major surgery within 1 month; 6. Systolic pressure =180 mmHg or diastolic pressure =110 mmHg; 7. Platelet count < 100×109/L; 8. Heparin therapy or oral anticoagulation therapy within 48 hours; 9. Severe disease with a life expectancy of less than 3 months; 10. Blood glucose < 50 mg/dL (2.7mmol/L); 11. Patients who have received any other investigational drug or device within 3 months; 12. Researchers consider patients inappropriate to participate in the registry. -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Butyphthalide combined with rtPA
Intravenous treatment with 25mg butyphthalide, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with 25mg butyphthalide 2 times/day for 14 days, followed by oral butyphthalide capsule (0.2g 3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines.
rtPA
Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines

Locations

Country Name City State
China General Hospital of ShenYang Military Region ShenYang

Sponsors (1)

Lead Sponsor Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of mRS score (0-2) (90 days) Percentage of mRS score (0-2) at 90 days 90 days
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