Status:
COMPLETED
Supplements, Placebo, or Rosuvastatin Study
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
AstraZeneca
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for choleste...
Detailed Description
Few well-controlled trials have studied the LDL-lowering effects of dozens of marketed "cholesterol health" dietary supplements. Prior research suggests most U.S. consumers believe cholesterol health ...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any assessment is performed.
- U.S. adults with primary hypercholesterolemia, 40-75 years of age.
- Not currently taking statins or one of the dietary supplements included in the trial. Patients willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate.
- LDL-cholesterol between 70 and 189 mg/dL.
- Patients without diabetes mellitus and a 10-year risk of ASCVD between 5 and \<20% using the pooled cohort risk equation. \* Or Patients with diabetes mellitus in females 50-60 years of age or males 40-50 years of age with an LDL-C between 70-189 mg/dL and with an ASCVD risk below 20%.
Exclusion
- Age \< 40 or \>75 years of age
- Women who are pregnant, plan to become pregnant within the next 6 months, or are breastfeeding.
- Documented liver dysfunction or history of elevated LFTs indicating active liver disease
- Documented chronic renal dysfunction within the past two years defined as an eGFR\<30mL/min/m2.
- Known hypersensitivity to rosuvastatin or any supplement under investigation (i.e. shellfish allergy, etc.).
- Currently taking any prescription statin, or other prescription medication/supplements to treat elevated cholesterol or triglycerides.
- Currently taking a medication/supplement that has known interaction with rosuvastatin, including fenofibrate, gemfibrozil, HIV medications, colchicine, cyclosporine, warfarin, anti-viral medications to treat Hepatitis C, regorafenib, and darolutamide.
- Are unwilling to discontinue prohibited dietary supplement(s) for 4 weeks prior to participation or during the course of the trial. Other non-prohibited supplements will be permitted if doses have been stable for at least 4 weeks.
- Known cardiovascular disease including a history of prior MI, stroke/TIA, PAD or prior revascularization procedures of the heart or vasculature (e.g. CABG, stenting, PCI etc.).
- Fasting Triglycerides \>200mg/dl.
- In the opinion of the investigator, any other condition that will preclude participation in the study.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT04846231
Start Date
April 23 2021
End Date
July 19 2022
Last Update
May 25 2023
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195