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Prevention study for Healthy Elderly Individuals With High LDL-cholesterol or Risk of...
Official title Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
ClinicalTrials.gov ID: NCT03770312
What this study is testing
What is Low intensity statin?
Low intensity statin is an investigational medicine, being studied as a potential treatment for healthy elderly individuals with high ldl-cholesterol or risk of cardiovascular disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older. Healthy volunteers may be eligible.
You may be able to join if
- "1. Adults aged 70 years or older as of the date of written consent, meeting one of the criteria in items 2-5)
- Patients with no prior statin use or who have discontinued statin therapy for at least 4 weeks, with no cardiovascular risk factors\ and...
- Patients with no prior statin use or who have discontinued statins for at least 4 weeks, with one or more cardiovascular disease risk factors\ and...
- For patients currently taking statins, with 0 cardiovascular disease risk factors\ and LDL-cholesterol levels of 95-114 mg/dL
- For patients currently taking statins, with 1 or more cardiovascular disease risk factors\ and LDL-cholesterol levels of 50-114 mg/dL
You likely can't join if
- (any):
- Individuals who have been diagnosed with cancer within the last 5 years.
- Individuals who have high level of serum ALT (\>2 upper normal limit).
- Individuals who have serum creatinine ≥2 mg/dL.
- Individuals who have been diagnosed with cardiovascular disease (\>50% stenosis of coronary artery on imaging study, percutaneous transluminal...
- Individuals who have been diagnosed with peripheral artery disease (\>50% stenosis of peripheral artery on imaging study, or ankle brachial index...
See the full eligibility criteria
- "1. Adults aged 70 years or older as of the date of written consent, meeting one of the criteria in items 2-5)
- Patients with no prior statin use or who have discontinued statin therapy for at least 4 weeks, with no cardiovascular risk factors\ and LDL-cholesterol levels of 160-189 mg/dL
- Patients with no prior statin use or who have discontinued statins for at least 4 weeks, with one or more cardiovascular disease risk factors\ and LDL-cholesterol levels of 80-189 mg/dL
- For patients currently taking statins, with 0 cardiovascular disease risk factors\ and LDL-cholesterol levels of 95-114 mg/dL
- For patients currently taking statins, with 1 or more cardiovascular disease risk factors\ and LDL-cholesterol levels of 50-114 mg/dL
- Cardiovascular Disease Risk Factors
- Male
- Family history of early cardiovascular disease: myocardial infarction, angina, peripheral vascular disease, ischemic stroke; men \<55 years, women \<65 years
- Diabetes: One or more of the following five criteria: HbA1c ≥6.5%, fasting blood glucose ≥126 mg/dL, postprandial 2-hour blood glucose ≥200 mg/dL, random blood glucose ≥200 mg/dL with typical symptoms like polyuria, or...
- Hypertension: Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or use of antihypertensive medication
- Current smoker
- HDL-cholesterol \<40 mg/dL
- (any):
- Individuals who have been diagnosed with cancer within the last 5 years.
- Individuals who have high level of serum ALT (\>2 upper normal limit).
- Individuals who have serum creatinine ≥2 mg/dL.
- Individuals who have been diagnosed with cardiovascular disease (\>50% stenosis of coronary artery on imaging study, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, or myocardial...
- Individuals who have been diagnosed with peripheral artery disease (\>50% stenosis of peripheral artery on imaging study, or ankle brachial index \<0.9 or ≥1.3).
- Individuals who have been diagnosed with uncontrolled hyperthyrodism or hypothyroidism.
- Individuals who are taking drug that can interact with statin.
- Individuals who have physical disability to live daily life.
- Individuals with genetic disorders such as galactose intolerance (including preparations containing lactose)"
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.