Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke
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|ClinicalTrials.gov Identifier: NCT00499902|
Recruitment Status : Terminated (CO Phase 2 data did not show sufficient improvement in cath opening at higher dose/concentration evaluated. Nuvelo ended further clinical dev of alfimeprase.)
First Posted : July 12, 2007
Last Update Posted : April 24, 2008
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Drug: alfimeprase||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||May 2008|
|Estimated Study Completion Date :||May 2008|
This is a two-stage study. The first stage is in a three-tier dose escalation format, followed by a second stage during which subjects will be randomized in an equal proportion to up to 3 qualifying dose arms.
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.
- Symptomatic intracerebral hemorrhage (ICH) defined as a greater than or equal to 4-point increase in NIHSS compared to baseline at the time of CT evidence of ICH within 24 hours of study drug administration.
- Recanalization of primary arterial occlusive lesion (AOL) using the Thrombolysis in Myocardial Infarction (TIMI) classification; a score of II or III will be considered success.
- Relative hypotension requiring treatment (i.e. volume expanders and/or vasopressors)
- New cardiac events (e.g., cardiac ischemia, congestive heart failure, and dysrhythmia)
- Relative hypotension not requiring treatment
- Major bleeding events (TIMI definition)
- Hemorrhagic transformation: hemorrhagic infarction (Type 1 and 2), parenchymal hematoma formation (Type 1 and 2)
- Intracerebral hemorrhage outside of the stroke territory
- New AIS
- AEs/SAEs/All cause mortality
- Changes in chemistry, hematology, coagulation, and alpha-2-macroglobulin parameters based on central laboratory measurements
- Anti-alfimeprase antibody detection based on central laboratory measurements
- Recanalization of the primary AOL
- Global reperfusion of the primary AOL distal vascular bed defined by the Thrombolysis in Cerebral Infarction (TICI) score
- Neurological benefit as assessed by individual and combined analysis of NIHSS, mRS, and BI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499902
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|Study Director:||Susan M Begelman, MD||ARCA Biopharma, Inc.|