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)
Verified date | February 2009 |
Source | Viron Therapeutics Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Viron Therapeutics Inc |
United States, Canada,
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 |
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