Clinical trial NCT00243308: Serp-1 for the Treatment of Acute Coronary Syndrome
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Unstable Angina
Coronary Atherosclerosis
Coronary Restenosis
Keywords: Anti-inflammatory agents
unstable plaque
acute coronary syndrome
Lead sponsor: Viron Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Safety (Adverse events collected until 6 months post-dose)
Secondary outcomes:
measure: Inflammatory marker analysis
measure: MACE
measure: Restenosis at 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Vicotria
country: Canada
facility: Victoria Heart Institute
state: British Columbia
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Chief Clinical Officer- Viron Therapeutics
name: Alexandra Lucas, MD
role: STUDY_DIRECTOR
affiliation: Director- Montreal Heart Institute Research Centre
name: Jean-Claude Tardif, MD
role: STUDY_CHAIR
References:
citation: 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.