Protocol Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects. The purpose of this study is to evaluate the safety of NBP treatment compared with placebo in subjects with mild to moderate acute ischemic stroke (AIS). Male and female adult subjects between 18-80 years will participate. Approximately 400 eligible subjects will be enrolled study wide at multiple sites. Subjects will participate in the study for 90 days includng a 30-day drug treatment period and a 60-day follow-up period, or until a discontinuation criterion is met.
The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on NOA in community practice. The primary goal is to address several key treatment and management issues surrounding patients with either AIS or ICH on anticoagulant therapy. In particular, attention will be focused on coagulation tests, utilization of thrombolytic therapy
for AIS, treatment patterns and clinical outcomes for AIS and ICH patients on anticoagulant therapy. The acquisition of such findings will be of critical importance to help fill in gaps on guideline recommendations and provide insights into the management of AIS and ICH patients on treatment with
new anticoagulants. This will allow physicians to feel more confident in anticoagulation therapy while improving the care and outcomes of patients on these agents who have stroke complications.
CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy procedure plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenting plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors.