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OPTIMIZE-APT: Tailored Versus Conventional Antiplatelet Therapy After Intravascular Imaging-guided Drug-eluting Stent Implantation

Study acronym: OPTIMIZE-APT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 3 changed
See other at-risk trials from Asan Medical Center

Record History

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  1. Eligibility criteria shortened, about 20 words Show 4 more changesShow less
    • Secondary endpoints revised (5)
    • Site details revised at 4 of 33 sites
    • Study description expanded, about 5 words
    • Study title expanded, about 1 word
  2. Eligibility criteria expanded, about 49 words
    • Study description expanded, about 9 words
    • Study title revised
    v9
  3. Primary endpoint(s) modified
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 5
    v8
  4. Primary completion pushed from Aug 30, 2027 to Dec 31, 2027
    • Trial sites expanded: 25 → 33 locations
    • Study completion pushed from Dec 31, 2028 to Dec 31, 2032
    • Study description expanded, about 6 words
    v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 24 to 25v5
  2. Study sites: 23 to 24
    • Eligibility criteria revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jul 30, 2027 to Aug 30, 2027
    • Start date changed from estimate of Jul 30, 2022 to Oct 21, 2022
    • Eligibility criteria expanded, about 64 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)
Trial Details
NCT Number NCT05418556
Lead Sponsor Asan Medical Center
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 3,944 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov