Phase
Condition
Myocardial Ischemia
Chest Pain
Hypercholesterolemia
Treatment
Placebo
DFV890
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female participants aged between 18 - 85 years (inclusive) at the start ofscreening will be included.
Subjects must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI =Body weight (kg) / [Height (m)]2
Documented spontaneous myocardial infarction (MI) (diagnosed according to theuniversal MI criteria with or without evidence of ST segment elevation) at least 30days before the start of screening.
Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening.Screening values must be separated by a minimum of 8 days. The initial hsCRP valuemust be a minimum of 30 days after the qualifying MI or after any percutaneouscoronary intervention (PCI) performed separately from the qualifying MI.
For participants on statin therapy (HMG-CoA reductase inhibitor), as clinicallyindicated, participants must be on a stable regimen (at least 4 weeks beforerandomization), with no planned statin dose changes over the course of the trialtreatment period. Unplanned statin dose changes during the trial treatment periodmay occur.
Exclusion
Exclusion Criteria:
Patients receiving concomitant medications that are known to be strong or moderateinducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, stronginhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatmentcannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to Day 1 and for the duration of the study.
Patients with suspected or proven immunocompromised state at screening
History of ongoing, chronic, or major recurrent infectious disease, at thediscretion of the investigator, at the start of screening.
Use of any biologic drugs targeting the immune system within 26 weeks of Day 1
Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 6 monthsprior to the start of screening.
Symptomatic Class IV heart failure (New York Heart Association) at the start ofscreening.
Planned coronary revascularization (PCI or CABG) or any other major surgicalprocedure during the study.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Novartis Investigative Site
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Valley Clinical Trials
Northridge, California 91325
United StatesSite Not Available
Valley Clinical Trials CPRT128A2302
Northridge, California 91325
United StatesActive - Recruiting
Excel Medical Clinical Trials LLC
Boca Raton, Florida 33434
United StatesSite Not Available
Novartis Investigative Site
Boca Raton, Florida 33434
United StatesActive - Recruiting
Novartis Investigative Site
Jacksonville, Florida 32209-6511
United StatesActive - Recruiting
University of Florida -Jacksonville UF Health Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
University of Florida Health Science Center
Jacksonville, Florida 32209
United StatesSite Not Available
University of Florida Health Science Center UF Health Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
Novartis Investigative Site
Greensboro, North Carolina 27410
United StatesActive - Recruiting
Triad Clinical Trials LLC
Greensboro, North Carolina 27410
United StatesSite Not Available
Monument Health Clinical Research
Rapid City, South Dakota 57701
United StatesSite Not Available
Monument Health Clinical Research A Depart Of Monument Health
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Novartis Investigative Site
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Novartis Investigative Site
Tacoma, Washington 98405
United StatesActive - Recruiting
Universal Research Group LLC
Tacoma, Washington 98405
United StatesSite Not Available
Universal Research Group LLC Suite 202
Tacoma, Washington 98405
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.