Serp-1 for the Treatment of Acute Coronary Syndrome

Sponsor

Viron Therapeutics Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT00243308

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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)

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammatory marker analysis []
MACE []
Restenosis at 6 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington	District of Columbia	United States	20010
2	University of Florida	Gainesville	Florida	United States	32610-0277
3	Spectrum Health	Grand Rapids	Michigan	United States	49525
4	Victoria Heart Institute	Vicotria	British Columbia	Canada	V8R 4R2
5	Foothills Medical Center	Calgary	Ontario	Canada	T2N 2T9
6	London Health Sciences Centre	London	Ontario	Canada	N6A 5C1
7	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
8	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