Unstable AnginaPhase 2NCT00243308
Serp-1 for the Treatment of Acute Coronary Syndrome
A Phase 2 study testing Serine proteinase-1 (Serp-1) in people with Unstable Angina and Coronary Atherosclerosis, run by Viron Therapeutics Inc at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unstable Angina, Coronary Atherosclerosis, Coronary Restenosis
- What is being tested?
- Serine proteinase-1 (Serp-1)
- How many people
- 72 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2005to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
- Scheduled for PCI
Who cannot join
- CABG within 6 months
- Acute ST elevation, eligible for thrombolysis on initial examination
- Coronary lesions with total thrombotic occlusions
- Current immunosuppressant therapy
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada5 sites
Foothills Medical Center
Calgary, Ontario, T2N 2T9
London Health Sciences Centre
London, Ontario, N6A 5C1
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Victoria Heart Institute
Vicotria, British Columbia, V8R 4R2
United States3 sites
University of Florida
Gainesville, Florida, 32610-0277
Spectrum Health
Grand Rapids, Michigan, 49525
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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)
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.
Read the 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.
- Being tested
- Serine proteinase-1 (Serp-1)
- Keywords
- Anti-inflammatory agents, unstable plaque, acute coronary syndrome
- Medical subject headings
- Angina, Unstable, Coronary Artery Disease, Coronary Restenosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serine proteinase-1 (Serp-1)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse events collected until 6 months post-dose)
Secondary outcomes (3)
Inflammatory marker analysis
MACE
Restenosis at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2008
- Study completionDec 2008
Why it stopped: Third dose group not recruited due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unstable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viron Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandra Lucas, MD, Study director, Chief Clinical Officer- Viron TherapeuticsJean-Claude Tardif, MD, Study chair, Director- Montreal Heart Institute Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243308
- Sponsor's protocol ID
- Serp-1-01-002
- Status last verified
- Feb 2009
- First submitted
- 19 Oct 2005
- Last updated
- 6 Feb 2009
- Results posted
- No
Publications
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.
PubMed 21062996
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00243308
- Acronym / sponsor ID
- Serp-1-01-002
- Keywords
- Anti-inflammatory agents, unstable plaque, acute coronary syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Third dose group not recruited due to slow enrollment.
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Viron Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
- Scheduled for PCI
Key exclusion criteria (4 listed)
- CABG within 6 months
- Acute ST elevation, eligible for thrombolysis on initial examination
- Coronary lesions with total thrombotic occlusions
- Current immunosuppressant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serine proteinase-1 (Serp-1) | Drug | – |
Primary outcome
Safety (Adverse events collected until 6 months post-dose)
3 secondary outcomes
Inflammatory marker analysis
MACE
Restenosis at 6 months
Results and safety
The study was stopped early (reason given: Third dose group not recruited due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Derived from this study: PubMed 21062996Tardif 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Lucas, MD study director
Chief Clinical Officer- Viron Therapeutics
Jean-Claude Tardif, MD study chair
Director- Montreal Heart Institute Research Centre
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serine proteinase-1 (Serp-1) in people with Unstable Angina and Coronary Atherosclerosis, run by Viron Therapeutics Inc at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Third dose group not recruited due to slow enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Adverse events collected until 6 months post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.