Serp-1 for the Treatment of Acute Coronary Syndrome

Unstable Angina Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00243308
• Other study ID #: Serp-1-01-002
• Status: Terminated
• Phase: Phase 2
• First received: October 19, 2005
• Last updated: February 5, 2009
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Viron Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Restenosis
• Myocardial Ischemia
• Non-ST Elevated Myocardial Infarction
• Unstable Angina

Intervention

Drug:
• Serine proteinase-1 (Serp-1)

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Victoria Heart Institute	Vicotria	British Columbia
United States	University of Florida	Gainesville	Florida
United States	Spectrum Health	Grand Rapids	Michigan
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Viron Therapeutics Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Adverse events collected until 6 months post-dose)
Secondary	Inflammatory marker analysis
Secondary	MACE
Secondary	Restenosis at 6 months