Serp-1 for the Treatment of Acute Coronary Syndrome

NCT00243308 | Terminated Phase 2

• 1 other identifier: Serp-1-01-002
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Unstable Angina; Coronary Atherosclerosis; Coronary Restenosis

Keywords

Anti-inflammatory agents; unstable plaque; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Safety (Adverse events collected until 6 months post-dose)

Secondary Outcomes (3)

• Inflammatory marker analysis

• MACE

• Restenosis at 6 months

Interventions

Serine proteinase-1 (Serp-1) DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
• Scheduled for PCI

You may not qualify if:

• CABG within 6 months
• Acute ST elevation, eligible for thrombolysis on initial examination
• Coronary lesions with total thrombotic occlusions
• Current immunosuppressant therapy

Sponsors & Collaborators

• Viron Therapeutics Inc: lead

Study Sites (8)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32610-0277, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49525, United States

Location

Victoria Heart Institute

Vicotria, British Columbia, V8R 4R2, Canada

Location

Foothills Medical Center

Calgary, Ontario, T2N 2T9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5C1, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

• Tardif JC, L'Allier PL, Gregoire J, Ibrahim R, McFadden G, Kostuk W, Knudtson M, Labinaz M, Waksman R, Pepine CJ, Macaulay C, Guertin MC, Lucas A. A randomized controlled, phase 2 trial of the viral serpin Serp-1 in patients with acute coronary syndromes undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Dec;3(6):543-8. doi: 10.1161/CIRCINTERVENTIONS.110.953885. Epub 2010 Nov 9.

  PMID: 21062996 DERIVED

MeSH Terms

Conditions

Angina, Unstable; Coronary Artery Disease; Coronary Restenosis; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis

Study Officials

• Alexandra Lucas, MD

  Chief Clinical Officer- Viron Therapeutics

  STUDY DIRECTOR

• Jean-Claude Tardif, MD

  Director- Montreal Heart Institute Research Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 21, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 6, 2009

Record last verified: 2009-02

Locations

US (3); CA (5)