Dalcetrapib's effect on heart risk in patients with recent heart issues and specific genetics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 clinical trial is a placebo-controlled, randomized, double-blind study designed to evaluate the effects of Dalcetrapib on cardiovascular risk in patients who have recently experienced acute coronary syndrome (ACS) and possess a specific genetic profile. Participants will undergo genetic testing to confirm the presence of the AA genotype at the ADCY9 gene variant before being randomized to receive either Dalcetrapib or a placebo. The study will track participants for primary events over time, with assessments conducted through virtual or clinic visits every three months. Enrollment may begin during hospitalization for ACS or shortly after discharge.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Fairhope, Alabama, United States Recruiting
• Research Site
  Huntsville, Alabama, United States Recruiting
• Research Site
  Mobile, Alabama, United States Recruiting
• Research Site
  Scottsdale, Arizona, United States Recruiting
• Research Site
  Tucson, Arizona, United States Recruiting

+181 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: David Kallend, MBBS
• Email: dkallend@dalcorpharma.com
• Phone: +41 79 174 1830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.