New study tests best statin dose for seniors to prevent heart attacks

NCT ID NCT03770312

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a low or moderate dose of statin works better and causes fewer muscle problems in healthy adults aged 70 and older who have high cholesterol or heart disease risk. About 724 participants will be randomly assigned to one of two statin doses and followed for up to 48 months. The goal is to find the safest and most effective way to prevent heart attacks, strokes, and other cardiovascular events in older adults.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 724 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

"Inclusion criteria 1. Adults aged 70 years or older as of the date of written consent, meeting one of the criteria in items 2-5) 2. 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 3. 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 4. For patients currently taking statins, with 0 cardiovascular disease risk factors\* and LDL-cholesterol levels of 95-114 mg/dL 5. 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 the use of antidiabetic medication * Hypertension: Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or use of antihypertensive medication * Current smoker * HDL-cholesterol \<40 mg/dL Exclusion criteria (any): 1. Individuals who have been diagnosed with cancer within the last 5 years. 2. Individuals who have high level of serum ALT (\>2 upper normal limit). 3. Individuals who have serum creatinine ≥2 mg/dL. 4. 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 infarction). 5. 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). 6. Individuals who have been diagnosed with uncontrolled hyperthyrodism or hypothyroidism. 7. Individuals who are taking drug that can interact with statin. 8. Individuals who have physical disability to live daily life. 9. Individuals with genetic disorders such as galactose intolerance (including preparations containing lactose)"

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine

    RECRUITING

    Seoul, 03722, South Korea