Serp-1 for the Treatment of Acute Coronary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Unstable Angina, Coronary Atherosclerosis, Coronary Restenosis

Intervention / Treatment
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* Drug: Serine proteinase-1 (Serp-1)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Serine proteinase-1 (Serp-1)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse events collected until 6 months post-dose) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker analysis |  |  | 
| MACE |  |  | 
| Restenosis at 6 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-inflammatory agents, unstable plaque, acute coronary syndrome