RECRUITING

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).

Official Title

A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants With Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT Trial)

Quick Facts

Study Start:2024-05-16
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06305559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * LDL \>70md/dL
  2. * Total coronary plaque \> 75mm3
  3. * BMI 18-40
  4. * Max tolerated lipid modifying therapy
  5. * eGFR greater/equal to 40
  1. * Contraindications for CCTA
  2. * History of coronary artery bypass graft
  3. * Active liver disease

Contacts and Locations

Study Contact

Global Clinical Trial Lead
CONTACT
+27 82 495 9889
shayleen.vanvuuren@fortrea.com
Claudia Forkel
CONTACT
+49 151 64549618

Study Locations (Sites)

NGMR
Hialeah, Florida, 33016
United States

Collaborators and Investigators

Sponsor: NewAmsterdam Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-16
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-05-16
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Lipidemia
  • Coronary Artery Disease
  • Plaque, Atherosclerotic