Gene-Targeted drug aims to prevent second heart attacks

NCT ID NCT05918861

Disease control Sponsor: DalCor Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether the drug dalcetrapib can reduce the risk of major heart problems like heart attacks in people who have a specific genetic makeup (AA genotype) and have recently had a heart-related event. About 2,000 participants will receive either dalcetrapib or a placebo for up to several years. The goal is to see if this personalized approach can prevent future cardiovascular events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Dalcetrapib
What this could lead to: If successful, this could provide a new treatment option for people with a specific genetic profile to lower their risk of future heart attacks.
What could go wrong: This is a large phase 3 trial, but previous studies of similar drugs have failed. The benefit may be limited to a small genetic subgroup, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute coronary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

185 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site
WITHDRAWN

Alexander City, Alabama, 35010, United States
Research Site
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

More trials for these conditions

Other studies related to the condition(s) this trial covers.