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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-005140-16 |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| The Cleveland Clinic | OTHER |
| Duke University | OTHER |
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The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: KAI-9803 | Experimental |
| |
| A2: KAI-9803 | Experimental |
| |
| A3: KAI-9803 | Experimental |
| |
| A4: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAI-9803 | Drug | STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of KAI-9803 on infarct size as assessed by CK-MB AUC | During the index hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias | Within the first 3 months after Myocardial Infarction | |
| The safety and tolerability of KAI-9803 by IV infusion to acute STEMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Bell, MD | KAI Pharmaceuticals, Inc | Study Director |
| A.Michael Lincoff, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24796339 | Derived | Lincoff AM, Roe M, Aylward P, Galla J, Rynkiewicz A, Guetta V, Zelizko M, Kleiman N, White H, McErlean E, Erlinge D, Laine M, Dos Santos Ferreira JM, Goodman S, Mehta S, Atar D, Suryapranata H, Jensen SE, Forster T, Fernandez-Ortiz A, Schoors D, Radke P, Belli G, Brennan D, Bell G, Krucoff M; PROTECTION AMI Investigators. Inhibition of delta-protein kinase C by delcasertib as an adjunct to primary percutaneous coronary intervention for acute anterior ST-segment elevation myocardial infarction: results of the PROTECTION AMI Randomized Controlled Trial. Eur Heart J. 2014 Oct 1;35(37):2516-23. doi: 10.1093/eurheartj/ehu177. Epub 2014 May 5. |
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| Within the first 3 months after Myocardial Infarction |
| Assess left ventricular function by imaging | Within the first 3 months after Myocardial Infarction |
| Escondido |
| California |
| 92025 |
| United States |
| Torrance | California | 90509 | United States |
| Tampa | Florida | 33613 | United States |
| Atlanta | Georgia | 30309 | United States |
| Downers Grove | Illinois | 60515 | United States |
| Lombard | Illinois | 60148 | United States |
| Peoria | Illinois | 61602 | United States |
| Valparaiso | Indiana | 46383 | United States |
| Omaha | Nebraska | 68131 | United States |
| Williamsville | New York | 14221 | United States |
| Greensboro | North Carolina | 27410 | United States |
| High Point | North Carolina | 27262 | United States |
| Zanesville | Ohio | 43701 | United States |
| Oklahoma City | Oklahoma | 77030 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Danville | Pennsylvania | 17822 | United States |
| Bedford Park | Australia |
| Boxhill | Australia |
| Epping | Australia |
| Fremantle | Australia |
| Hobart | Australia |
| Kogarah | Australia |
| Liverpool | Australia |
| Parkville | Australia |
| Perth | Australia |
| St Leonards | Australia |
| Victoria | Australia |
| Antwerp | Belgium |
| Bonheiden | Belgium |
| Brussels | Belgium |
| Liège | Belgium |
| Roeselare | Belgium |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Hamilton | Ontario | Canada |
| Kitchner | Ontario | Canada |
| Newmarket | Ontario | Canada |
| Toronta | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| New Brunswick | Canada |
| Brno | Czechia |
| Hradec Králové | Czechia |
| Karlovy Vary | Czechia |
| Labem | Czechia |
| Liberec | Czechia |
| Olomouc | Czechia |
| Ostrava | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Zlín | Czechia |
| Aalborg | Denmark |
| Copenhagen | Denmark |
| Hellerup | Denmark |
| Odense | Denmark |
| Helsinki | Finland |
| Turku | Finland |
| Berlin | Germany |
| Halle | Germany |
| Hamburg | Germany |
| Heidelberg | Germany |
| Lübeck | Germany |
| Magdeburg | Germany |
| Mannheim | Germany |
| München | Germany |
| Rostock | Germany |
| Budapest | Hungary |
| Pécs | Hungary |
| Szeged | Hungary |
| Székesfehérvár | Hungary |
| Zalaegerszeg | Hungary |
| Afula | Israel |
| Ashkelon | Israel |
| BeerSheva | Israel |
| Haifa | Israel |
| Holon | Israel |
| Jerusalem | Israel |
| Kfar Saba | Israel |
| Safed | Israel |
| Ẕerifin | Israel |
| Pesaro | Italy |
| Rome | Italy |
| Rozzano | Italy |
| Amsterdam | Netherlands |
| Nieuwegein | Netherlands |
| Rotterdam | Netherlands |
| Zwolle | Netherlands |
| Auckland | New Zealand |
| Christchurch | New Zealand |
| Dunedin | New Zealand |
| Hamilton | New Zealand |
| Nelson | New Zealand |
| Arendal | Norway |
| Bergen | Norway |
| Bialystok | Poland |
| Bielsko-Biala | Poland |
| Dąbrowa Górnicza | Poland |
| Gdansk | Poland |
| Gdynia | Poland |
| Krakow | Poland |
| Lubin | Poland |
| Poznan | Poland |
| Szczecin | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Almada | Portugal |
| Amadora | Portugal |
| Carnaxide | Portugal |
| Alicante | Spain |
| Barcelona | Spain |
| El Palmar Murcia | Spain |
| León | Spain |
| Madrid | Spain |
| Santa Cruz de Tenerife | Spain |
| Seville | Spain |
| Vigo Pontevedra | Spain |
| Gothenburg | Sweden |
| Helsingborg | Sweden |
| Linköping | Sweden |
| Lund | Sweden |
| Malmö | Sweden |
| Örebro | Sweden |
| Stockholm | Sweden |
| Sundsvall | Sweden |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| D007238 | Infarction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D007511 | Ischemia |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C527142 | KAI 9803 |
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