Serp-1 for the Treatment of Acute Coronary Syndrome

This study has been terminated.
(Third dose group not recruited due to slow enrollment.)
Sponsor:
Information provided by:
Viron Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00243308
First received: October 19, 2005
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Unstable Angina
Coronary Atherosclerosis
Coronary Restenosis
Drug: Serine proteinase-1 (Serp-1)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Viron Therapeutics Inc:

Primary Outcome Measures:
  • Safety (Adverse events collected until 6 months post-dose)

Secondary Outcome Measures:
  • Inflammatory marker analysis
  • MACE
  • Restenosis at 6 months

Estimated Enrollment: 72
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243308

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0277
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49525
Canada, British Columbia
Victoria Heart Institute
Vicotria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Foothills Medical Center
Calgary, Ontario, Canada, T2N 2T9
London Health Sciences Centre
London, Ontario, Canada, N6A 5C1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Viron Therapeutics Inc
Investigators
Study Director: Alexandra Lucas, MD Chief Clinical Officer- Viron Therapeutics
Study Chair: Jean-Claude Tardif, MD Director- Montreal Heart Institute Research Centre
  More Information

No publications provided by Viron Therapeutics Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00243308     History of Changes
Other Study ID Numbers: Serp-1-01-002
Study First Received: October 19, 2005
Last Updated: February 5, 2009
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Viron Therapeutics Inc:
Anti-inflammatory agents
unstable plaque
acute coronary syndrome

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arterial Occlusive Diseases
Coronary Disease
Coronary Stenosis
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014