Serp-1 for the Treatment of Acute Coronary Syndrome



Status:Terminated
Conditions:Angina, Angina, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:10/14/2017
Start Date:October 2005
End Date:December 2008

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A Phase 2, Multicentre, Double-Blind, Placebo-Controlled, Dose Escalating Trial of the Safety, Pharmacokinetics, and Biological Activity of 3 Consecutive Daily Doses of Serp-1 When Added to Conventional Therapy in Patients With Acute Coronary Syndromes (Non ST-Elevation Myocardial Infarction and/or Unstable Angina)

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.

Inclusion Criteria:

- Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina
in the 24 hours before hospital admission

- Scheduled for PCI

Exclusion Criteria:

- CABG within 6 months

- Acute ST elevation, eligible for thrombolysis on initial examination

- Coronary lesions with total thrombotic occlusions

- Current immunosuppressant therapy
We found this trial at
4
sites
Grand Rapids, Michigan 49503
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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1900 Richmond Road
Vicotria, British Columbia V8R 4R2
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Vicotria,
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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