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This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg/kg RO4905417 before PCI | Experimental |
| |
| 5 mg/kg RO4905417 before PCI | Experimental |
| |
| Placebo before PCI | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Procedure | at least 1 hour and up to 24 hours after completion of drug infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI | from baseline to 24 hours post PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in troponin I at 8 hours post PCI | from baseline to 8 hours post PCI | |
| Peak and AUC for troponin I | 24 hours post PCI | |
| Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI |
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Inclusion Criteria:
Exclusion 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 |
|---|---|---|---|
| 27852589 | Derived | Stahli BE, Gebhard C, Duchatelle V, Cournoyer D, Petroni T, Tanguay JF, Robb S, Mann J, Guertin MC, Wright RS, L L'Allier P, Tardif JC. Effects of the P-Selectin Antagonist Inclacumab on Myocardial Damage After Percutaneous Coronary Intervention According to Timing of Infusion: Insights From the SELECT-ACS Trial. J Am Heart Assoc. 2016 Nov 16;5(11):e004255. doi: 10.1161/JAHA.116.004255. | |
| 23500230 |
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| RO4905417 | Drug | 5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI |
|
| RO4905417 | Drug | 20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI |
|
| placebo | Drug | iv infusion, completed at least 1 hour and up to 24 hours before PCI |
|
| from baseline to 24 hours post PCI |
| Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI | from baseline to Day 120 post PCI |
| Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI | from baseline to Day 30 post PCI |
| Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) | 120 days |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Los Angeles | California | 90022 | United States |
| Salinas | California | 93901 | United States |
| Littleton | Colorado | 80120 | United States |
| Farmington | Connecticut | 06030 | United States |
| Boynton Beach | Florida | 33472 | United States |
| Kissimmee | Florida | 34741 | United States |
| Ocala | Florida | 34471 | United States |
| Sarasota | Florida | 34239 | United States |
| St. Petersburg | Florida | 33701 | United States |
| Tampa | Florida | 33613 | United States |
| Vero Beach | Florida | 32960 | United States |
| Columbus | Georgia | 31904 | United States |
| Aurora | Illinois | 60504 | United States |
| Fort Wayne | Indiana | 46804 | United States |
| Iowa City | Iowa | 52242 | United States |
| Wichita | Kansas | 67214 | United States |
| Louisville | Kentucky | 40205 | United States |
| Shreveport | Louisiana | 71103 | United States |
| Baltimore | Massachusetts | 21287 | United States |
| Hyannis | Massachusetts | 02601 | United States |
| Bay City | Michigan | 48708 | United States |
| Petoskey | Michigan | 49770 | United States |
| Saint Paul | Minnesota | 55102 | United States |
| Ridgewood | New Jersey | 07450 | United States |
| Johnson City | New York | 13790 | United States |
| Raleigh | North Carolina | 27610 | United States |
| Bismarck | North Dakota | 58501 | United States |
| Springfield | Ohio | 45505 | United States |
| Toledo | Ohio | 43606 | United States |
| Oklahoma City | Oklahoma | 73109 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Chambersburg | Pennsylvania | 17201 | United States |
| Houston | Texas | 77024 | United States |
| Edmonton | Alberta | T6G1Z1 | Canada |
| Vancouver | British Columbia | V5Z 1L8 | Canada |
| Victoria | British Columbia | V8R 4R2 | Canada |
| Hamilton | Ontario | L8L 2X2 | Canada |
| Newmarket | Ontario | L3Y 2R2 | Canada |
| Ottawa | Ontario | K1Y 4W7 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| Montreal | Quebec | H1T 1C8 | Canada |
| Montreal | Quebec | H2W 1T8 | Canada |
| Montreal | Quebec | H4J 1C5 | Canada |
| Québec | Quebec | G1V 4G5 | Canada |
| Saint-Charles-Borromée | Quebec | J6E 6J2 | Canada |
| Heerlen | 6419 PC | Netherlands |
| Leeuwarden | 8934 AD | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Rotterdam | 3079 DZ | Netherlands |
| Tilburg | 5042 AD | Netherlands |
| Bydgoszcz | 85-826 | Poland |
| Gdansk | 80-952 | Poland |
| Gdynia | 81-348 | Poland |
| Józefów | 05-410 | Poland |
| Katowice | 40-635 | Poland |
| Krakow | 31-202 | Poland |
| Krakow | 31-501 | Poland |
| Lodz | 91-347 | Poland |
| Starogard Gdański | 83-200 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 02-637 | Poland |
| Warsaw | 04-628 | Poland |
| Wejherowo | 84-200 | Poland |
| Wroclaw | 50-981 | Poland |
| Derived |
| Tardif JC, Tanguay JF, Wright SR, Duchatelle V, Petroni T, Gregoire JC, Ibrahim R, Heinonen TM, Robb S, Bertrand OF, Cournoyer D, Johnson D, Mann J, Guertin MC, L'Allier PL. Effects of the P-selectin antagonist inclacumab on myocardial damage after percutaneous coronary intervention for non-ST-segment elevation myocardial infarction: results of the SELECT-ACS trial. J Am Coll Cardiol. 2013 May 21;61(20):2048-55. doi: 10.1016/j.jacc.2013.03.003. Epub 2013 Mar 10. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| C000604431 | inclacumab |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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