The purpose of this research study is to evaluate the desired outcome and safety of the study drug, tenecteplase, compared to a placebo in patients with an acute ischemic stroke. Tenecteplase is approved by the health authorities for the treatment of heart attack, but it is not approved for stroke.
Participants will be screened within 4.5 to 24 hours after the onset of the stroke and will undergo 2 followup MRIs within 96 hours.
Follow-up clinic visits will occur at 30 and 90 days after study treatment. Total study duration is about 3 months.
This is an ancillary study on the Phase 3 parent trial (CREST-2) in which patients with asymptomatic high grade carotid artery stenosis have enrolled to receive either a novel intensive medical management plan alone, or in combination with either Carotid Endarterectomy (CEA) or Carotid artery stenting (CAS). Patients enrolled in CREST-H will undergo a baseline MRI and some patients will also undergo a followup MRI at 1 year. The purpose is to determine whether cognition can be improved by revascularization among the subset of CREST-2 patients with hemodynamic impairment and mild cognitive impairment at baseline.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban (Eliquis) versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. 1100 subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
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.
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.