Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Launched by DALCOR PHARMACEUTICALS · Jun 15, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Dalcetrapib to see how it affects heart health in patients who have recently experienced a serious heart event known as Acute Coronary Syndrome (ACS). The trial is specifically looking for individuals with a certain genetic profile, called the AA genotype. If you are over 45 years old, have been hospitalized for ACS in the last three months, and are stable (not experiencing heart symptoms), you may be eligible to participate.
If you join the study, you will first undergo a genetic test to confirm your eligibility. Participants will be randomly assigned to receive either Dalcetrapib or a placebo (a treatment that looks the same but has no active medication) for a certain period. Throughout the trial, your health will be monitored closely, and you may need to follow up with study visits after you leave the hospital. This research aims to better understand how Dalcetrapib can help reduce the risk of future heart problems in patients with this specific genetic background.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.
- • Both male and female subjects age 45 years and over at screening visit (V1)
- • AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)
- • Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
- • Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
- • Randomization within 3 months of the index ACS event
- Exclusion Criteria:
- • Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
- • Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least one highly effective method of contraception.
- • New York Heart Association (NYHA) Class III or IV heart failure
- • Index ACS event presumed due to uncontrolled hypertension
- • Systolic blood pressure (BP) \>180 mmHg and/or diastolic blood pressure \>110 mmHg at the time of randomization despite anti-hypertensive therapy
- • Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level \>3 x ULN within 6 months prior to randomization (excluding index event)
- • History of persistent and unexplained creatine phosphokinase (CPK) levels \> 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
- • Last known eGFR \< 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
- • History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.
- • Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study
- • Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
- • Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
About Dalcor Pharmaceuticals
DalCor Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative therapies aimed at addressing cardiovascular diseases. Focused on advancing clinical research, DalCor leverages cutting-edge science and technology to discover and develop novel treatments that improve patient outcomes and enhance quality of life. With a commitment to rigorous clinical trials and a collaborative approach, DalCor seeks to bring transformative solutions to the healthcare landscape, ultimately striving to meet the unmet needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, Ontario, Canada
Tucson, Arizona, United States
Newport Beach, California, United States
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Newmarket, Ontario, Canada
Baltimore, Maryland, United States
Moncton, New Brunswick, Canada
Laval, Quebec, Canada
Victoria, British Columbia, Canada
Port Charlotte, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Tampa, Florida, United States
West Reading, Pennsylvania, United States
Memphis, Tennessee, United States
Norfolk, Virginia, United States
Calgary, Alberta, Canada
Detroit, Michigan, United States
Augusta, Georgia, United States
Scarborough, Ontario, Canada
Trois Rivières, Quebec, Canada
Los Angeles, California, United States
Long Beach, California, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
Chicoutimi, Quebec, Canada
Cambridge, Ontario, Canada
Montréal, Quebec, Canada
Louisville, Kentucky, United States
Seattle, Washington, United States
San Francisco, California, United States
Park Ridge, Illinois, United States
Cleveland, Ohio, United States
Dallas, Texas, United States
Huntington Beach, California, United States
Toronto, Ontario, Canada
New Orleans, Louisiana, United States
Allentown, Pennsylvania, United States
Miami, Florida, United States
Iowa City, Iowa, United States
Philadelphia, Pennsylvania, United States
Waco, Texas, United States
Greenfield Park, Quebec, Canada
Huntsville, Alabama, United States
Sarasota, Florida, United States
Kalamazoo, Michigan, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Kingston, Ontario, Canada
Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Mobile, Alabama, United States
La Jolla, California, United States
Loveland, Colorado, United States
Washington, District Of Columbia, United States
Safety Harbor, Florida, United States
Duluth, Minnesota, United States
Saint Louis, Missouri, United States
Lincoln, Nebraska, United States
Hackensack, New Jersey, United States
Johnson City, New York, United States
Winston Salem, North Carolina, United States
Canton, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Spartanburg, South Carolina, United States
Beaumont, Texas, United States
Dallas, Texas, United States
Edmonton, Alberta, Canada
London, Ontario, Canada
Hialeah, Florida, United States
Ocala, Florida, United States
Tallahassee, Florida, United States
Bethesda, Maryland, United States
Atlanta, Georgia, United States
Stanford, California, United States
Lexington, Kentucky, United States
Cincinnati, Ohio, United States
North Little Rock, Arkansas, United States
Pinehurst, North Carolina, United States
Boca Raton, Florida, United States
Miami Lakes, Florida, United States
San Antonio, Texas, United States
Omaha, Nebraska, United States
Saskatoon, Saskatchewan, Canada
Springfield, Missouri, United States
Stony Brook, New York, United States
Caguas, , Puerto Rico
Clearwater, Florida, United States
Pembroke Pines, Florida, United States
Fort Wayne, Indiana, United States
Amarillo, Texas, United States
Newport News, Virginia, United States
Poughkeepsie, New York, United States
Vancouver, British Columbia, Canada
Chicago, Illinois, United States
Lafayette, Louisiana, United States
New Orleans, Louisiana, United States
Tupelo, Mississippi, United States
Rock Hill, South Carolina, United States
Laval, Quebec, Canada
West Des Moines, Iowa, United States
Toledo, Ohio, United States
Merrillville, Indiana, United States
Midland, Michigan, United States
Traverse City, Michigan, United States
Las Vegas, Nevada, United States
Winchester, Virginia, United States
La Crosse, Wisconsin, United States
Torrance, California, United States
Columbia, Maryland, United States
Victorville, California, United States
Saint Cloud, Minnesota, United States
Rapid City, South Dakota, United States
Moncton, New Brunswick, Canada
Cambridge, Ontario, Canada
Bangor, Maine, United States
Hammond, Louisiana, United States
Terrebonne, Quebec, Canada
Corpus Christi, Texas, United States
Burnaby, British Columbia, Canada
Trois Rivières, Quebec, Canada
New Haven, Connecticut, United States
Ypsilanti, Michigan, United States
Jackson, Tennessee, United States
Kingwood, Texas, United States
Norfolk, Virginia, United States
Edgewood, Kentucky, United States
Albuquerque, New Mexico, United States
Chicoutimi, Quebec, Canada
Garden Grove, California, United States
West Hills, California, United States
Golden, Colorado, United States
Littleton, Colorado, United States
Alexander City, Alabama, United States
Largo, Florida, United States
Newburgh, Indiana, United States
Rocky Mount, North Carolina, United States
Springfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Terrebonne, Quebec, Canada
Largo, Florida, United States
Bossier City, Louisiana, United States
Bridgewater, New Jersey, United States
Linden, New Jersey, United States
Albany, New York, United States
Victoria, Texas, United States
Winnipeg, Manitoba, Canada
Hazel Crest, Illinois, United States
Chambersburg, Pennsylvania, United States
Houston, Texas, United States
Québec, Quebec, Canada
Midland, Michigan, United States
Oak Ridge, Tennessee, United States
Doral, Florida, United States
Homestead, Florida, United States
Cypress, Texas, United States
Fairhope, Alabama, United States
Cutler Bay, Florida, United States
Bowie, Maryland, United States
Sanford, North Carolina, United States
Newmarket, Ontario, Canada
Gainesville, Florida, United States
Jonesboro, Arkansas, United States
Mckinney, Texas, United States
Hartford, Connecticut, United States
Richmond, Indiana, United States
Winter Haven, Florida, United States
Pomona, New Jersey, United States
Spartanburg, South Carolina, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Powell, Tennessee, United States
North Vancouver, British Columbia, Canada
Coon Rapids, Minnesota, United States
Mesquite, Texas, United States
Moncton, New Brunswick, Canada
Scarborough, Ontario, Canada
Amarillo, Texas, United States
Glenview, Illinois, United States
Fort Myers, Florida, United States
Duluth, Minnesota, United States
Acworth, Georgia, United States
Norfolk, Virginia, United States
Mobile, Alabama, United States
Clearwater, Florida, United States
Fort Lauderdale, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Tallahassee, Florida, United States
Newburgh, Indiana, United States
West Des Moines, Iowa, United States
Winston Salem, North Carolina, United States
Canton, Ohio, United States
Springfield, Ohio, United States
Zanesville, Ohio, United States
Greeneville, Tennessee, United States
Houston, Texas, United States
Saint John's, New Foundland, Canada
Lévis, Quebec, Canada
Québec City, Quebec, Canada
Saint Charles Borromee, Quebec, Canada
Saint Jérôme, Quebec, Canada
Kissimmee, Florida, United States
Acworth, Georgia, United States
Eatonton, Georgia, United States
Mandeville, Louisiana, United States
Calgary, Alberta, Canada
Kamloops, British Columbia, Canada
Surrey, British Columbia, Canada
Halifax, Nova Scotia, Canada
Brampton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec City, Canada
Longueuil, Quebec City, Canada
Sherbrooke, Quebec City, Canada
Valleyfield, Quebec City, Canada
Montréal, Quebec, Canada
Rimouski, Quebec, Canada
Dearborn, Michigan, United States
Linwood, Pennsylvania, United States
Port Arthur, Texas, United States
Abbotsford, British Columbia, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
North Miami Beach, Florida, United States
Nottingham, Maryland, United States
Richmond, Indiana, United States
Greeneville, Tennessee, United States
Jefferson City, Tennessee, United States
Granby, Quebec, Canada
Saint Charles Borromee, Quebec, Canada
Saint Jérôme, Quebec, Canada
St Hubert, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Carolina, , Puerto Rico
Saint John's, New Foundland, Canada
Sherbrooke, Quebec City, Canada
Québec, Quebec, Canada
Poughkeepsie, New York, United States
Jefferson City, Tennessee, United States
Bloomingdale, Illinois, United States
Victoria, British Columbia, Canada
Saint John's, Newfoundland And Labrador, Canada
Calgary, Alberta, Canada
Lévis, Quebec, Canada
Saint Jérôme, Quebec, Canada
Saint Louis, Missouri, United States
Edmonton, Alberta, Canada
Newport Beach, California, United States
Patients applied
Trial Officials
David Kallend, MBBS
Study Director
DalCor
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported