Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke

NCT ID: NCT03394950

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2021-05-29

Brief 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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

rtPA combined with Butyphthalide

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.

Group Type: EXPERIMENTAL

Butyphthalide combined with rtPA

Intervention Type: DRUG

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 compared with placebo

Intravenous treatment with placebo injection, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with placebo injection 2 times/day for 14 days, followed by oral placebo capsule (3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines.

Group Type: ACTIVE_COMPARATOR

rtPA

Intervention Type: DRUG

Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines

Interventions

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.

Intervention Type: DRUG

rtPA

Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines

Intervention Type: DRUG

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui-Sheng Chen

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

chen huisheng, doctor

Role: STUDY_DIRECTOR

General Hospital of Shenyang Military Region

Locations

General Hospital of ShenYang Military Region

Shenyang, , China

Countries

China

Other Identifiers

k201731

Identifier Type: -

Identifier Source: org_study_id