NCT00499902

Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke

Phase 2, Multicenter, Open-Label, Two-Stage Study to Evaluate the Safety and Efficacy of Intra-Arterial Catheter-Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke (CARNEROS-1)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: ARCA Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify a safe and effective bolus dose of intra-arterial/intra-thrombus alfimeprase in acute ischemic stroke (AIS) 3 to 9 hours from symptom onset.

Detailed description

Currently approved drug therapy for AIS is limited by the need to treat within 3 hours of symptom onset. Alfimeprase acts to degrade fibrin directly and is inactivated locally by circulating alpha-2 macroglobulin. This study will determine whether treatment with alfimeprase facilitates rapid restoration of arterial blood flow with avoidance of symptomatic hemorrhagic conversion in subjects with AIS within 3 to 9 hours of symptom onset.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	alfimeprase	Alfimeprase will be given as a single bolus of 1mg/2mL, or a split bolus of 5mg/2mL or 10mg/2mL in a three-tier dose escalation format. The 5mg and 10mg doses will be administered as split doses with 1/2 of the total dose given initially and 1/2 of the total dose given 30 minutes after the initial dose.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-07-12
• Last updated: 2008-04-24

Locations

22 sites across 2 countries: United States, Canada