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 |
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.
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.
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
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4
sites
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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110 Irving St NW
Washington, District of Columbia 20010
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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