Low- versus moderate-intensity rosuvastatin for preventing heart disease in people over 70
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
This trial will test whether low-dose (2.5 mg) or moderate-dose (10 mg) rosuvastatin better prevents heart problems and causes fewer side effects in people aged 70 and older who do not have cardiovascular disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 724 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03770312 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, randomized trial enrolls adults aged 70 or older without prior cardiovascular disease and assigns them 1:1 to rosuvastatin 2.5 mg or rosuvastatin 10 mg. Participants return at 3 and 6 months for blood tests, physical exams, and questionnaires about muscle symptoms, with a primary follow-up of six months and an optional total follow-up of four years. The trial measures clinical outcomes and safety signals, including lipid changes and statin-associated adverse effects. Recruitment is planned over two years across participating centers.
Who should consider this trial
Good fit: Ideal candidates are people aged 70 or older without prior cardiovascular disease who meet the LDL and statin-use criteria (for example, specified LDL ranges depending on presence of risk factors and whether they are statin-naive or previously on statins).
Not a fit: Patients with established cardiovascular disease, those who require high-intensity statin therapy for secondary prevention, or individuals with contraindications to statins are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the results could identify a dose that prevents cardiovascular events while reducing side effects in older adults, improving safety and quality of care.
How similar studies have performed: Large randomized trials and meta-analyses support statin benefit in older adults, but randomized head-to-head comparisons of low- versus moderate-intensity statins specifically in people over 70 are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
"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)"
Where this trial is running
Seoul
- Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.