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New treatment option for Acute Coronary Syndrome
Official title Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
ClinicalTrials.gov ID: NCT05918861
What this study is testing
What is Dalcetrapib?
Dalcetrapib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute coronary syndrome.
Also referred to as Cholesterol Ester Transfer Protein Inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- people with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this...
- Both male and female people 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, people must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
You likely can't join if
- 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...
- 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
- people with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST...
See the full eligibility criteria
- people 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 people 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, people 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
- 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
- people 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...
- 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 people 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
- people 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
- people who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization
The study team makes the final eligibility decision.
Where it's taking place
- Alexander City, Alabama, United States
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- North Little Rock, Arkansas, United States
- Garden Grove, California, United States
- Huntington Beach, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Stanford, California, United States
- Torrance, California, United States
- West Hills, California, United States
+ 183 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexander City, Alabama, United States; Birmingham, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Mobile, Alabama, United States; Scottsdale, Arizona, United States and 197 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.