Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease Clinical Trial
Official title:
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study
| Verified date | February 2020 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 aged over 75 years. Since side effects of statin are more
common in elderly individuals than in younger individuals, clinical guidelines recommend that
use of low intensity statin is considered in elderly individuals. However, there are few
randomized clinical trials evaluating the safety and efficacy of different intensity statins
in elderly individuals.
This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety
between low and high intensity statin for primary prevention of cardiovascular disease in
elderly individuals.
| Status | Not yet recruiting |
| Enrollment | 2484 |
| Est. completion date | January 16, 2026 |
| Est. primary completion date | January 16, 2026 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 76 Years to 85 Years |
| Eligibility |
Inclusion Criteria: (1 and, 2 or 3) 1. Individuals aged 76-85 years old. 2. Individuals who have serum LDL-cholesterol of 160-189 mg/dL. 3. Individuals who have serum LDL-cholesterol of 80-159 mg/dL and =1 cardiovascular risk factor (male, diabetes, hypertension, smoking, serum HDL-cholesterol <40 mg/dL, or family history of premature cardiovascular disease). Exclusion Criteria: (any) 1. Individuals who have been diagnosed with cancer within the last 5 years. 2. Individuals who have high level of serum aspartate aminotransferase (AST), alanine amino- transferse (ALT) (>2 upper normal limit). 3. past history of myopathy or rhabdomyolysis or Creatine Kinase (CK)> 2-fold of upper normal limit 4. Individuals who have serum creatinine =2 mg/dL. 5. 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). 6. 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). 7. Individuals who have been diagnosed with hyperthyroidism or hypothyroidism. 8. Individuals who are taking drug that can interact with statin. 9. Individuals who have physical disability to live daily life. 10. genetic disorder such as galactose intolerance, etc |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. | They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. These symptoms have persisted for at least 2 weeks. The symptoms resolve within 2 weeks of stopping the study drug. The symptoms reoccur within 4 weeks of restarting the medication. |
3 months | |
| Primary | Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. | They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. These symptoms have persisted for at least 2 weeks. The symptoms resolve within 2 weeks of stopping the study drug. The symptoms reoccur within 4 weeks of restarting the medication. |
6 months | |
| Primary | Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF). | 3 months | ||
| Primary | Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF). | 6 months | ||
| Primary | Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) | 3 months | ||
| Primary | Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) | 6 months | ||
| Secondary | Clinical outcomes | cardiovascular death nonfatal myocardial infarction nonfatal ischemic stroke or transient ischemic attack coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft) hospitalization for unstable angina |
4 years |