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A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 24, 2024 (before its estimated August 16, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Aug 2025 to Aug 16, 2025
    • Study completion date: Aug 2026 to Aug 16, 2026
    • Secondary endpoints: details revised at 2 of 5 entries
    v4
  2. Primary completion date: Apr 2022 to Aug 2025v3 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 2023 to Aug 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 4 to 5
    • Site details revised
    • Study description expanded, about 4 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2019 to Aug 14, 2019
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.
Trial Details
NCT Number NCT03947229
Lead Sponsor Yonsei University
Conditions
(from sponsor)		 Coronary Artery Disease, DES
Related terms Coronary Artery Disease, Hemorrhage
Enrollment 3,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov