A Phase 2 interventional study of Serine proteinase-1 (Serp-1) in Unstable Angina, Coronary Atherosclerosis and Coronary Restenosis, sponsored by Viron Therapeutics Inc. Terminated at 8 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-02-06.
Sponsored by Viron Therapeutics Inc · Phase 2, Interventional, and Diagnostic
Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.
A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 72 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Viron Therapeutics Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Safety (Adverse events collected until 6 months post-dose)
Inflammatory marker analysis
MACE
Restenosis at 6 months
This study is terminated, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Viron Therapeutics Inc