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Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated November 18, 2025 (before its estimated January 16, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv7 Show 6 more changesShow less
    • Enrollment target: 2484 to 724
    • Eligibility criteria expanded, about 139 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 33 words
    • Site details revised
    • Study title revised
  2. Notable Trial status: Terminated to Not Yet Recruitingv6 Show 6 more changesShow less
    • Enrollment target: 14 to 2484
    • Primary and study completion dates: Aug 14, 2019 to Jan 16, 2026
    • Start date: Apr 16, 2019 to Mar 5, 2020
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
  3. Stopped Trial status: Recruiting to Terminated Sponsor's reason: It was needed to change the study design, and further progress was impossible. In this regard, we decided to terminate the study.
    • Enrollment target: estimated 2234 to confirmed 14
    • Primary and study completion dates changed from estimate of Aug 15, 2024 to Aug 14, 2019
    • Site details revised
    v5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2019 to Apr 16, 2019
    • Site details revised
    v4
  5. Minor Start date: Jan 2019 to Mar 2019v3
  6. Minor Start date: Dec 10, 2018 to Jan 2019v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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. 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 cardiovacsular disease in elderly individuals.
Trial Details
NCT Number NCT03770312
Lead Sponsor Yonsei University
Conditions
(from sponsor)
Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease
Enrollment 724 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov