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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of ShenYang Military Region

Shenyang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 years;
Diagnosis of anterior circulation infarct;
First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
Time from onset to treatment ≤4.5 hours;
SBP/DBP ≤ 180/110mmHg;
No hemorrhagic imaging changes showed in CT;
Signed informed consent by patient self or legally authorized representatives.

Exclusion criteria

History of stroke within 3 months;
History of intracranial hemorrhage;
Suspected subarachnoid hemorrhage;
Intracranial tumour, vascular malformation or arterial aneurysm;
Major surgery within 1 month;
Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
Platelet count < 100×109／L;
Heparin therapy or oral anticoagulation therapy within 48 hours;
Severe disease with a life expectancy of less than 3 months;
Blood glucose < 50 mg/dL (2.7mmol/L);
Patients who have received any other investigational drug or device within 3 months;
Researchers consider patients inappropriate to participate in the registry. -

Treatment and study plan

Butyphthalide combined with rtPA

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

Drug

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

Primary outcomes

Percentage of mRS score (0-2) (90 days)

Time frame: 90 days

Percentage of mRS score (0-2) at 90 days

Sponsors and collaborators

Lead sponsor

Hui-Sheng Chen

Other

Registry information

Official study title

Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke (BRAIS)：a Pilot, Prospective, Random, and Double Blinded Multi-center Study

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jan 9, 2018
Registry last updated: Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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