NCT03394950

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hui-Sheng Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	rtPA	Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines

Timeline

• Start date: 2018-05-25
• Primary completion: 2021-05-29
• Completion: 2021-05-29
• First posted: 2018-01-09
• Last updated: 2021-06-02

Locations

1 site across 1 country: China