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Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study

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ClinicalTrials.gov Identifier: NCT03770312
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease Drug: Low intensity statin Drug: Moderate intensity statin Phase 4

Detailed Description:
Healthy elderly individuals who are eligible to use of statin for primary prevention will be enrolled. They are randomly assigned to moderate intensity statin group and low intensity statin group by 1:1 manner. Blood tests, physical examinations, and evaluation of statin associated muscle symptoms are conducted every 3 months after enrollment. General medical care for prevention of cardiovascular disease is continued after 6 months. The accrual period is 2 years and follow-up period is 4 years, so the total study period is 6 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : August 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low intensity statin group
Taking low intensity statin
Drug: Low intensity statin
Use of low intensity statin for primary prevention of cardiovascular disease.

Active Comparator: Moderate intensity statin group
Taking moderate intensity statin
Drug: Moderate intensity statin
Use of moderate intensity statin for primary prevention of cardiovascular disease.




Primary Outcome Measures :
  1. Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. [ Time Frame: 3 months ]
    1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.
    2. These symptoms have persisted for at least 2 weeks.
    3. The symptoms resolve within 2 weeks of stopping the study drug.
    4. The symptoms reoccur within 4 weeks of restarting the medication.

  2. Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. [ Time Frame: 6 months ]
    1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.
    2. These symptoms have persisted for at least 2 weeks.
    3. The symptoms resolve within 2 weeks of stopping the study drug.
    4. The symptoms reoccur within 4 weeks of restarting the medication.

  3. Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF). [ Time Frame: 3 months ]
  4. Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF). [ Time Frame: 6 months ]
  5. Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 3 months ]
  6. Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinical outcomes [ Time Frame: 4 years ]

    Major adverse cardiac atherosclerotic cardiovascular events, defined as the composite endpoint comprised of the death from coronary heart disease, nonfatal non-procedure-related myocardial infarction, or fatal or nonfatal stroke.

    All cause death. All adverse events.




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Ages Eligible for Study:   76 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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 hyperthyroidism or hypothyroidism.
  7. Individuals who are taking drug that can interact with statin.
  8. Individuals who have physical disability to live daily life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770312


Locations
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Korea, Republic of
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Sang-Hak Lee, MD    82-2-2228-8460    SHL1106@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03770312     History of Changes
Other Study ID Numbers: 4-2018-0631
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents