Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115999
Status:
COMPLETED
Last Update Posted:
2008-01-15
First Post:
2005-06-26
Brief Title:
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries
Sponsor:
ARCA Biopharma Inc
Organization:
ARCA Biopharma Inc
Study Overview
Official Title:
Phase 3 Multicenter Multi-National Randomized Partial Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 03 mgkg with placebo in acute peripheral arterial occlusion PAO as measured by a 30 day open vascular free surgery rate
Detailed Description:
There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion PAO Currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic lytic state that does not distinguish between physiologic and pathologic thrombosis In general mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage A direct thrombolytic agent like alfimeprase with a rapid mechanism of action and a potentially safer bleeding risk profile could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NAPA-2 | None | None | None |