Phase
Condition
Myocardial Ischemia
Coronary Artery Disease
Heart Disease
Treatment
Placebo
TriLipix
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-85
CAC 30-400, within 12 months of screening visit, OR intermediate stenosis oncoronary artery CTA or invasive angiography (40-69% visual estimation) without thepresence of obstructive (≥70% visual estimation) Stenosis within 3 months ofscreening visit
LDL-C ≥ 100 mg/dL and LDL-C ≤190 mg/dL at screening or baseline visit
TG>150 mg/dL and TG/HDL>3.5 at screening or baseline visit
10 Year Framingham risk score of ≤ 10%
Ability and willingness to provide consent and Authorization for use of PHI
Exclusion
Exclusion Criteria:
Previous coronary revascularization (PCI, CABG)
Current lipid lowering therapy (includes statins, fibrates, niacin, omega 3 agents,intestinal cholesterol absorption inhibitors, cholestatic cholesterol absorptionagents and other anti-lipemic agents.)
Known genetic form of hypercholesterolemia (e.g. familial hypercholesterolemia,etc.)
Creatinine 1.5 mg/dL or greater at baseline visit
Fasting serum triglycerides 500 mg/dL or greater at screening or baseline visit
Inability to perform CTA:
Arrhythmia precluding diagnostic CT examination
Known moderate or severe allergy to iodine-based contrast agents (mild priorreactions that could be treated as an outpatient or that could be prevented bypre-medication in the past do not constitute exclusion)
Uncontrolled hypertension (SBP>180 mmHg or DBP>130 mmHg on stable treatment)
Decompensated heart failure (NYHA class IV) at the time of enrollment
Known Pregnancy
Inability or unwillingness to consent and Authorization for use of PHI
Presence of any co-morbidity that makes life expectancy less than 24 months
Inability or unwillingness to comply with follow up procedures
Study Design
Study Description
Connect with a study center
Piedmont Hospital
Atlanta, Georgia 30309
United StatesSite Not Available
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