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| Name | Class |
|---|---|
| The Montreal Health Innovations Coordinating Center (MHICC) | OTHER |
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This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.
This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints.
Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalcetrapib | Experimental | Dalcetrapib 600 mg (two 300 mg tablets) orally once daily |
|
| Placebo | Placebo Comparator | Matching dalcetrapib placebo tablets (2 tablets) orally once per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalcetrapib | Drug | Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of any fatal or non-fatal myocardial infarction (MI) | Time to patients experiencing major cardiovascular events | Average of 30 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke | Time to patients experiencing major cardiovascular events | Average of 30 months from randomization |
| Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Kallend, MBBS | Contact | +41 79 174 1830 | dkallend@dalcorpharma.com | |
| Therese Heinonen, DVM | Contact | theinonen@dalcorpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| David Kallend, MBBS | DalCor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Withdrawn | Alexander City | Alabama | 35010 | United States | |
| Research Site |
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Placebo-controlled, randomized, double-blind, parallel group, multi-center
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With the exception of the statistician to the DSMB and the DSMB all other individuals will remain blinded until the final analysis of the primary study parameter.
| Placebo | Drug | matching placebo tablets |
|
|
Time to patients experiencing first and recurrent occurrences |
| Average of 30 months from randomization |
| Fatal and non-fatal MI | Time to patients experiencing first and recurrent occurrences | Average of 30 months from randomization |
| Recruiting |
| Birmingham |
| Alabama |
| 35211 |
| United States |
| Research Site | Recruiting | Fairhope | Alabama | 36532 | United States |
| Research Site | Recruiting | Huntsville | Alabama | 35801 | United States |
| Research Site | Recruiting | Mobile | Alabama | 36608 | United States |
| Research Site | Recruiting | Scottsdale | Arizona | 85258 | United States |
| Research Site | Recruiting | Tucson | Arizona | 85724 | United States |
| Research Site | Withdrawn | Jonesboro | Arkansas | 72405 | United States |
| Research Site | Recruiting | North Little Rock | Arkansas | 72117 | United States |
| Research Site | Withdrawn | Garden Grove | California | 92844 | United States |
| Research Site | Recruiting | Huntington Beach | California | 92648 | United States |
| Research Site | Recruiting | La Jolla | California | 92037 | United States |
| Research Site | Withdrawn | Long Beach | California | 90813 | United States |
| Research Site | Withdrawn | Los Angeles | California | 90025 | United States |
| Research Site | Not yet recruiting | Newport Beach | California | 92648 | United States |
| Research Site | Not yet recruiting | Newport Beach | California | 92658 | United States |
| Research Site | Recruiting | San Francisco | California | 94143 | United States |
| Research Site | Recruiting | Santa Barbara | California | 93105 | United States |
| Research Site | Recruiting | Stanford | California | 94305 | United States |
| Research Site | Recruiting | Torrance | California | 90502 | United States |
| Research Site | Recruiting | West Hills | California | 91307 | United States |
| Research Site | Recruiting | Aurora | Colorado | 80011 | United States |
| Research Site | Recruiting | Golden | Colorado | 80401 | United States |
| Research Site | Recruiting | Hartford | Connecticut | 06102 | United States |
| Research Site | Recruiting | New Haven | Connecticut | 06519 | United States |
| Research Site | Recruiting | Newark | Delaware | 19718 | United States |
| Research Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Research Site | Withdrawn | Boca Raton | Florida | 33434 | United States |
| Research Site | Terminated | Boca Raton | Florida | 33486 | United States |
| Research Site | Recruiting | Clearwater | Florida | 33756 | United States |
| Research Site | Not yet recruiting | Doral | Florida | 33166 | United States |
| Research Site | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
| Research Site | Recruiting | Fort Myers | Florida | 33908 | United States |
| Research Site | Not yet recruiting | Gainesville | Florida | 32608 | United States |
| Research Site | Withdrawn | Hialeah | Florida | 33013 | United States |
| Research Site | Recruiting | Homestead | Florida | 33030 | United States |
| Research Site | Recruiting | Jacksonville | Florida | 32209 | United States |
| Research Site | Withdrawn | Kissimmee | Florida | 34741 | United States |
| Research Site | Recruiting | Largo | Florida | 33777 | United States |
| Research Site | Recruiting | Miami | Florida | 33032 | United States |
| Research Site | Withdrawn | Miami | Florida | 33033 | United States |
| Research Site | Recruiting | Miami | Florida | 33136 | United States |
| Research Site | Recruiting | Miami | Florida | 33145 | United States |
| Research Site | Withdrawn | Miami | Florida | 33175 | United States |
| Research Site | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Research Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Research Site | Recruiting | Ocala | Florida | 34471 | United States |
| Research Site | Not yet recruiting | Orlando | Florida | 32803 | United States |
| Research Site | Recruiting | Pembroke Pines | Florida | 33024 | United States |
| Research Site | Not yet recruiting | Pensacola | Florida | 32502 | United States |
| Research Site | Recruiting | Port Charlotte | Florida | 33952 | United States |
| Research Site | Recruiting | Safety Harbor | Florida | 34695 | United States |
| Research Site | Recruiting | Sarasota | Florida | 34239 | United States |
| Research Site | Withdrawn | South Miami | Florida | 33143 | United States |
| Research Site | Withdrawn | Tallahassee | Florida | 32308 | United States |
| Research Site | Recruiting | Tampa | Florida | 33606 | United States |
| Research Site | Recruiting | Tampa | Florida | 33607 | United States |
| Research Site | Not yet recruiting | The Villages | Florida | 32162 | United States |
| Research Site | Recruiting | Winter Haven | Florida | 33881 | United States |
| Research Site | Withdrawn | Acworth | Georgia | 30101 | United States |
| Research Site | Recruiting | Atlanta | Georgia | 30310 | United States |
| Research Site | Recruiting | Atlanta | Georgia | 30322 | United States |
| Research Site | Recruiting | Augusta | Georgia | 30912 | United States |
| Research Site | Not yet recruiting | Gainesville | Georgia | 30501 | United States |
| Research Site | Recruiting | McDonough | Georgia | 30253 | United States |
| Research Site | Recruiting | Arlington Heights | Illinois | 60005 | United States |
| Research Site | Withdrawn | Bloomingdale | Illinois | 60108 | United States |
| Research Site | Not yet recruiting | Chicago | Illinois | 60612 | United States |
| Research Site | Recruiting | Chicago | Illinois | 60616 | United States |
| Research Site | Recruiting | Glenview | Illinois | 60026 | United States |
| Research Site | Withdrawn | Hazel Crest | Illinois | 60429 | United States |
| Research Site | Withdrawn | Park Ridge | Illinois | 60068 | United States |
| Research Site | Recruiting | Springfield | Illinois | 62702 | United States |
| Research Site | Active, not recruiting | Fort Wayne | Indiana | 46845 | United States |
| Research Site | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Research Site | Withdrawn | Merrillville | Indiana | 46410 | United States |
| Research Site | Recruiting | Munster | Indiana | 46321 | United States |
| Research Site | Recruiting | Newburgh | Indiana | 47630 | United States |
| Research Site | Recruiting | Richmond | Indiana | 47374 | United States |
| Research Site | Recruiting | Davenport | Iowa | 52801 | United States |
| Research Site | Recruiting | Iowa City | Iowa | 52242 | United States |
| Research Site | Active, not recruiting | West Des Moines | Iowa | 50266 | United States |
| Research Site | Recruiting | Kansas City | Kansas | 66160 | United States |
| Research Site | Not yet recruiting | Edgewood | Kentucky | 41017 | United States |
| Research Site | Recruiting | Lexington | Kentucky | 40536 | United States |
| Research Site | Withdrawn | Louisville | Kentucky | 40202 | United States |
| Research Site | Recruiting | Hammond | Louisiana | 70403 | United States |
| Research Site | Recruiting | Lafayette | Louisiana | 70503 | United States |
| Research Site | Withdrawn | Mandeville | Louisiana | 70448 | United States |
| Research Site | Recruiting | New Orleans | Louisiana | 70121 | United States |
| Research Site | Recruiting | Bangor | Maine | 04401 | United States |
| Research Site | Withdrawn | Baltimore | Maryland | 21215 | United States |
| Research Site | Recruiting | Bethesda | Maryland | 20814 | United States |
| Research Site | Withdrawn | Bowie | Maryland | 20715 | United States |
| Research Site | Withdrawn | Columbia | Maryland | 21044 | United States |
| Research Site | Active, not recruiting | Lutherville | Maryland | 21093 | United States |
| Research Site | Recruiting | Bay City | Michigan | 48708 | United States |
| Research Site | Recruiting | Dearborn | Michigan | 48126 | United States |
| Research Site | Recruiting | Detroit | Michigan | 48202 | United States |
| Research Site | Recruiting | Kalamazoo | Michigan | 49048 | United States |
| Research Site | Not yet recruiting | Lansing | Michigan | 48912 | United States |
| Research Site | Recruiting | Midland | Michigan | 48670 | United States |
| Research Site | Recruiting | Mount Clemens | Michigan | 48043 | United States |
| Research Site | Recruiting | Petoskey | Michigan | 49770 | United States |
| Research Site | Not yet recruiting | Traverse City | Michigan | 49684 | United States |
| Research Site | Recruiting | Ypsilanti | Michigan | 48197 | United States |
| Research Site | Not yet recruiting | Coon Rapids | Minnesota | 55433 | United States |
| Research Site | Withdrawn | Duluth | Minnesota | 55805 | United States |
| Research Site | Recruiting | Minneapolis | Minnesota | 55407 | United States |
| Research Site | Recruiting | Minneapolis | Minnesota | 55417 | United States |
| Research Site | Recruiting | Saint Cloud | Minnesota | 56303 | United States |
| Research Site | Recruiting | Tupelo | Mississippi | 38801 | United States |
| Research Site | Withdrawn | Springfield | Missouri | 65804 | United States |
| Research Site | Recruiting | St Louis | Missouri | 63110 | United States |
| Research Site | Recruiting | St Louis | Missouri | 63136 | United States |
| Research Site | Withdrawn | Lincoln | Nebraska | 68506 | United States |
| Research Site | Recruiting | Omaha | Nebraska | 68124 | United States |
| Research Site | Recruiting | Las Vegas | Nevada | 89102 | United States |
| Research Site | Recruiting | Bridgewater | New Jersey | 08807 | United States |
| Research Site | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Research Site | Recruiting | Pomona | New Jersey | 08240 | United States |
| Research Site | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Recruiting | Albany | New York | 12211 | United States |
| Research Site | Recruiting | Buffalo | New York | 14203 | United States |
| Research Site | Recruiting | Johnson City | New York | 13790 | United States |
| Research Site | Recruiting | New York | New York | 10028 | United States |
| Research Site | Recruiting | Poughkeepsie | New York | 12601 | United States |
| Research Site | Recruiting | Staten Island | New York | 10310 | United States |
| Research Site | Recruiting | Stony Brook | New York | 11794 | United States |
| Research Site | Recruiting | The Bronx | New York | 10467 | United States |
| Research Site | Withdrawn | Pinehurst | North Carolina | 28374 | United States |
| Research Site | Recruiting | Rocky Mount | North Carolina | 27804 | United States |
| Research Site | Not yet recruiting | Sanford | North Carolina | 27330 | United States |
| Research Site | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Research Site | Recruiting | Canton | Ohio | 44710 | United States |
| Research Site | Withdrawn | Cincinnati | Ohio | 45219 | United States |
| Research Site | Not yet recruiting | Cincinnati | Ohio | 45267 | United States |
| Research Site | Recruiting | Cleveland | Ohio | 44106 | United States |
| Research Site | Recruiting | Springfield | Ohio | 45504 | United States |
| Research Site | Recruiting | Toledo | Ohio | 43608 | United States |
| Research Site | Not yet recruiting | Bartlesville | Oklahoma | 74006 | United States |
| Research Site | Not yet recruiting | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Not yet recruiting | Tulsa | Oklahoma | 74104 | United States |
| Research Site | Not yet recruiting | Allentown | Pennsylvania | 18013 | United States |
| Research Site | Recruiting | Allentown | Pennsylvania | 18103 | United States |
| Research Site | Recruiting | Chambersburg | Pennsylvania | 17201 | United States |
| Research Site | Recruiting | Hershey | Pennsylvania | 17033 | United States |
| Research Site | Not yet recruiting | Langhorne | Pennsylvania | 19047 | United States |
| Research Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Not yet recruiting | Philadelphia | Pennsylvania | 19152 | United States |
| Research Site | Recruiting | West Reading | Pennsylvania | 19611 | United States |
| Research Site | Recruiting | Wyomissing | Pennsylvania | 19610 | United States |
| Research Site | Recruiting | Providence | Rhode Island | 02906 | United States |
| Research Site | Recruiting | Rock Hill | South Carolina | 29732 | United States |
| Research Site | Recruiting | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Recruiting | Rapid City | South Dakota | 57701 | United States |
| Research Site | Recruiting | Chattanooga | Tennessee | 37403 | United States |
| Research Site | Recruiting | Greeneville | Tennessee | 37745 | United States |
| Research Site | Recruiting | Jefferson City | Tennessee | 37760 | United States |
| Research Site | Recruiting | Memphis | Tennessee | 38120 | United States |
| Research Site | Recruiting | Oak Ridge | Tennessee | 37830 | United States |
| Research Site | Recruiting | Powell | Tennessee | 37849 | United States |
| Research Site | Recruiting | Amarillo | Texas | 79106 | United States |
| Research Site | Active, not recruiting | Beaumont | Texas | 77702 | United States |
| Research Site | Withdrawn | Corpus Christi | Texas | 78404 | United States |
| Research Site | Recruiting | Cypress | Texas | 77429 | United States |
| Research Site | Recruiting | Dallas | Texas | 75216 | United States |
| Research Site | Recruiting | Dallas | Texas | 75235 | United States |
| Research Site | Recruiting | Houston | Texas | 77070 | United States |
| Research Site | Recruiting | Houston | Texas | 77089 | United States |
| Research Site | Recruiting | Houston | Texas | 77090 | United States |
| Research Site | Recruiting | Kingwood | Texas | 77339 | United States |
| Research Site | Recruiting | McKinney | Texas | 75071 | United States |
| Research Site | Withdrawn | Mesquite | Texas | 75149 | United States |
| Research Site | Active, not recruiting | Port Arthur | Texas | 77642 | United States |
| Research Site | Not yet recruiting | San Antonio | Texas | 78207 | United States |
| Research Site | Recruiting | Victoria | Texas | 77901 | United States |
| Research Site | Active, not recruiting | Waco | Texas | 76712 | United States |
| Research Site | Not yet recruiting | Fredericksburg | Virginia | 22401 | United States |
| Research Site | Withdrawn | Newport News | Virginia | 23606 | United States |
| Research Site | Active, not recruiting | Norfolk | Virginia | 23504 | United States |
| Research Site | Recruiting | Richmond | Virginia | 23219 | United States |
| Research Site | Recruiting | Winchester | Virginia | 22601 | United States |
| Research Site | Recruiting | Seattle | Washington | 98122 | United States |
| Research Site | Withdrawn | Calgary | Alberta | T1Y0B4 | Canada |
| Research Site | Recruiting | Edmonton | Alberta | T6G2B7 | Canada |
| Research Site | Recruiting | Abbotsford British Columbia | British Columbia | V2S 0C2 | Canada |
| Research Site | Recruiting | Burnaby | British Columbia | V5G 2X6 | Canada |
| Research Site | Recruiting | Kamloops | British Columbia | V2C2T1 | Canada |
| Research Site | Withdrawn | North Vancouver | British Columbia | V7M 2H4 | Canada |
| Research Site | Not yet recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Withdrawn | Victoria | British Columbia | V8R 1B2 | Canada |
| Research Site | Recruiting | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Research Site | Recruiting | Moncton | New Brunswick | E1C 2Z3 | Canada |
| Research Site | Recruiting | Moncton | New Brunswick | E1G 1A7 | Canada |
| Research Site | Withdrawn | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Research Site | Recruiting | Halifax | Nova Scotia | B3H3A7 | Canada |
| Research Site | Not yet recruiting | Brampton | Ontario | L6R3J7 | Canada |
| Research Site | Recruiting | Cambridge | Ontario | N1R 6V6 | Canada |
| Research Site | Recruiting | Kingston | Ontario | K7L2V7 | Canada |
| Research Site | Recruiting | London | Ontario | N6A 5A5 | Canada |
| Research Site | Recruiting | Newmarket | Ontario | L3Y 2R2 | Canada |
| Research Site | Not yet recruiting | Ottawa | Ontario | K1Y4W7 | Canada |
| Research Site | Recruiting | Scarborough Village | Ontario | M1B 4Z8 | Canada |
| Research Site | Recruiting | Scarborough Village | Ontario | M1B 5N1 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Not yet recruiting | Toronto | Ontario | M5B 1W8 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| Research Site | Withdrawn | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Research Site | Recruiting | Granby | Quebec | J2G 1T7 | Canada |
| Research Site | Recruiting | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Research Site | Withdrawn | Laval | Quebec | H7M 3L9 | Canada |
| Research Site | Recruiting | Lévis | Quebec | G6V 9H4 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H1T1C8 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H3G1A4 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Recruiting | Québec | Quebec | G1R 2J6 | Canada |
| Research Site | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
| Research Site | Recruiting | Rimouski | Quebec | G5L5T1 | Canada |
| Research Site | Recruiting | Saint-Charles-Borromée | Quebec | J6E 6J2 | Canada |
| Research Site | Recruiting | Saint-Hubert | Quebec | J3Z 0C8 | Canada |
| Research Site | Recruiting | Saint-Jérôme | Quebec | J7Z 2V4 | Canada |
| Research Site | Recruiting | Terrebonne | Quebec | J6V 2H2 | Canada |
| Research Site | Recruiting | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Research Site | Recruiting | Sherbrooke | Quebec City | J1H5N4 | Canada |
| Research Site | Not yet recruiting | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Research Site | Withdrawn | Caguas | Puerto Rico | 00726 | Puerto Rico |
| Research Site | Withdrawn | Carolina | 00984 | Puerto Rico |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C411602 | dalcetrapib |
Not provided
Not provided
Not provided