Coronary Heart Disease, Graft Occlusion, VascularPhase 2NCT01245634
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
A Phase 2 study testing RO4905417 in people with Coronary Heart Disease, Graft Occlusion, Vascular, run by Hoffmann-La Roche at 38 sites in 2 countries.
Trial summary
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Graft Occlusion, Vascular
- What is being tested?
- RO4905417
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Dec 2010to May 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, > 18 and > 85 years of age
- Patients undergoing primary multi-vessel CABG with at least one saphenous vein graft. with or without cardiopulmonary bypass
- Body mass index (BMI) </= 35 kg/m2
Who cannot join
- Participation in previous studies evaluating RO4905417
- Positive for HIV, receiving antiretroviral drugs, or immuno-suppressed
- Acute infection at screening or active chronic infection within 3 months prior to CABG surgery
- Patients undergoing emergency cardiac surgery for an immediately life-threatening condition
- Patients undergoing concomitant valve surgery
- History of CABG (only patients without prior CABG surgery will be admitted to the study)
Show all 10Show fewer
- Left ventricular ejection fraction < 20%
- History of transient ischemic attack or stroke within the 12 weeks prior to the CABG procedure
- Significant renal or liver impairment
- Malignancy diagnosed within the previous 5 years (except for successfully resected basal cell cancer)
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States27 sites
Study site
Atlantis, Florida, 33462
Study site
Dallas, Texas, 75390-9063
Study site
Dearborn, Michigan, 48123
Study site
Duluth, Minnesota, 55805
Study site
Durham, North Carolina, 27710
Study site
Fort Wayne, Indiana, 46804
Study site
Huntsville, Alabama, 35801
Study site
Jacksonville, Florida, 32216
Study site
Kissimmee, Florida, 34741
Study site
Lexington, Kentucky, 405360293
Study site
Los Angeles, California, 90022
Study site
Los Angeles, California
Study site
Macon, Georgia, 31201
Study site
Memphis, Tennessee, 38120
Study site
Petoskey, Michigan, 49770
Study site
Richmond, Virginia, 23225
Study site
Richmond, Virginia, 23229
Study site
Royal Oak, Michigan, 48073
Study site
Saint Paul, Minnesota, 55102
Study site
Salt Lake City, Utah, 84124
Study site
Springfield, Illinois, 62702
Study site
Springfield, Illinois, 62769
Study site
Stony Brook, New York, 11794
Study site
Toledo, Ohio, 43606
Study site
Troy, Michigan, 48085
Study site
Tucson, Arizona, 85710
Study site
Washington, Missouri, 63090
Canada11 sites
Study site
Halifax, Nova Scotia, B3H 3A7
Study site
Hamilton, Ontario, L8L 2X2
Study site
Montreal, Quebec, H1T 1C8
Study site
Montreal, Quebec, H2X 0A9
Study site
Montreal, Quebec, H3A 1A1
Study site
Montreal, Quebec, H3T 1E2
Study site
Montreal, Quebec, H4J 1C5
Study site
Québec, Quebec, G1V 4G5
Study site
Saint John, New Brunswick, E2L 4L2
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5G 2C4
About this study
Official title: Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32 weeks.
- Being tested
- Placebo, RO4905417
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
iv infusion every 4 weeks, 32 weeks
RO4905417Drug
20 mg/kg iv infusion every 4 weeks, 32 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: RO4905417 |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
Measured: 1 year
Secondary outcomes (3)
Lumen diameter of saphenous vein grafts, as assessed by invasive angiography
Measured: 1 year
Proportion of patients needing revascularization
Measured: 1 year
Safety: Incidence of adverse events (including major adverse cardiovascular events)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2013
- Study completionMay 2013
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 Coronary Heart Disease, Graft Occlusion, VascularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245634
- Sponsor's protocol ID
- BP25601
- Status last verified
- Nov 2016
- First submitted
- 19 Nov 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Stahli BE, Tardif JC, Carrier M, Gallo R, Emery RW, Robb S, Cournoyer D, Blondeau L, Johnson D, Mann J, Lesperance J, Guertin MC, L'Allier PL. Effects of P-Selectin Antagonist Inclacumab in Patients Undergoing Coronary Artery Bypass Graft Surgery: SELECT-CABG Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):344-6. doi: 10.1016/j.jacc.2015.10.071. No abstract available.
PubMed 26796402
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing 20 mg/kg Dose of the Recombinant Human Monoclonal Antibody Against P-selectin in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
- ClinicalTrials.gov ID
- NCT01245634
- Acronym / sponsor ID
- BP25601
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Nov 2010 (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.
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: RO4905417 |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, > 18 and > 85 years of age
- Patients undergoing primary multi-vessel CABG with at least one saphenous vein graft. with or without cardiopulmonary bypass
- Body mass index (BMI) </= 35 kg/m2
Key exclusion criteria (10 listed)
- Participation in previous studies evaluating RO4905417
- Positive for HIV, receiving antiretroviral drugs, or immuno-suppressed
- Acute infection at screening or active chronic infection within 3 months prior to CABG surgery
- Patients undergoing emergency cardiac surgery for an immediately life-threatening condition
- Patients undergoing concomitant valve surgery
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 |
|---|---|---|
| Placeboiv infusion every 4 weeks, 32 weeks | Drug | B |
| RO490541720 mg/kg iv infusion every 4 weeks, 32 weeks | Drug | A |
Primary outcome
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
Time frame: 1 year
3 secondary outcomes
Lumen diameter of saphenous vein grafts, as assessed by invasive angiography
Time frame: 1 year
Proportion of patients needing revascularization
Time frame: 1 year
Safety: Incidence of adverse events (including major adverse cardiovascular events)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 26796402Stahli BE, Tardif JC, Carrier M, Gallo R, Emery RW, Robb S, Cournoyer D, Blondeau L, Johnson D, Mann J, Lesperance J, Guertin MC, L'Allier PL. Effects of P-Selectin Antagonist Inclacumab in Patients Undergoing Coronary Artery Bypass Graft Surgery: SELECT-CABG Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):344-6. doi: 10.1016/j.jacc.2015.10.071. No abstract available.
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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.
Clinical Trials study director
Hoffmann-La Roche
38 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 RO4905417 in people with Coronary Heart Disease, Graft Occlusion, Vascular, run by Hoffmann-La Roche at 38 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography (time frame: 1 year). 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 NCT01245634, 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 2 Nov 2016.