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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | iv infusion every 4 weeks, 32 weeks |
| |
| RO4905417 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Lumen diameter of saphenous vein grafts, as assessed by invasive angiography | 1 year | |
| Proportion of patients needing revascularization | 1 year | |
| Safety: Incidence of adverse events (including major adverse cardiovascular events) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26796402 | Derived | 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. |
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| Drug |
20 mg/kg iv infusion every 4 weeks, 32 weeks |
|
| 1 year |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Los Angeles | California | 90022 | United States |
| Los Angeles | California | United States |
| Atlantis | Florida | 33462 | United States |
| Jacksonville | Florida | 32216 | United States |
| Kissimmee | Florida | 34741 | United States |
| Macon | Georgia | 31201 | United States |
| Springfield | Illinois | 62702 | United States |
| Springfield | Illinois | 62769 | United States |
| Fort Wayne | Indiana | 46804 | United States |
| Lexington | Kentucky | 405360293 | United States |
| Dearborn | Michigan | 48123 | United States |
| Petoskey | Michigan | 49770 | United States |
| Royal Oak | Michigan | 48073 | United States |
| Troy | Michigan | 48085 | United States |
| Duluth | Minnesota | 55805 | United States |
| Saint Paul | Minnesota | 55102 | United States |
| Washington | Missouri | 63090 | United States |
| Stony Brook | New York | 11794 | United States |
| Durham | North Carolina | 27710 | United States |
| Toledo | Ohio | 43606 | United States |
| Memphis | Tennessee | 38120 | United States |
| Dallas | Texas | 75390-9063 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Richmond | Virginia | 23225 | United States |
| Richmond | Virginia | 23229 | United States |
| Saint John | New Brunswick | E2L 4L2 | Canada |
| Halifax | Nova Scotia | B3H 3A7 | Canada |
| Hamilton | Ontario | L8L 2X2 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H1T 1C8 | Canada |
| Montreal | Quebec | H2X 0A9 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Montreal | Quebec | H4J 1C5 | Canada |
| Québec | Quebec | G1V 4G5 | Canada |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000604431 | inclacumab |
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