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Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary endpoint(s) modified Enrollment increased: 360 → 1346 participants · Completion pushed from Sep 1, 2028 to Dec 1, 2028 · Eligibility criteria expanded, about 55 words · 3 morev4 Show 6 more changesShow less
    • Enrollment increased: 360 → 1346 participants
    • Completion pushed from Sep 1, 2028 to Dec 1, 2028
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints revised (26)
    • Study description expanded, about 9 words
    • Collaborators: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2025 to Oct 27, 2025 · Site details revised · Collaborators: 7 to 8v2 Show 3 more changesShow less
    • Start date changed from estimate of Sep 1, 2025 to Oct 27, 2025
    • Site details revised
    • Collaborators: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 1,346 patients with Stanford Type A aortic dissection, conducted between 2025 and 2028. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] within 6 hours before surgery and 30 mg im twice daily(at 6:00 AM and 6:00 PM, respectively for two days postoperatively or placebo in addition to standard care. Study outcomes include composite clinical endpoints, postoperative complications, and adverse events, which will be assessed through clinical evaluations, laboratory testing, and imaging studies at predefined intervals up to 90 days. The objective of this trial is to determine whether perioperative administration of ketorolac improves clinical outcomes in this patient population.
Trial Details
NCT Number NCT06968806
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: Guangdong Provincial People's Hospital, Huai'an First People's Hospital, Shandong Provincial Hospital, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Shihezi University, Xinhua Hospital of Ili Kazak Autonomous Prefecture, Henan Provincial Chest Hospital, First Affiliated Hospital of Zhejiang University
Conditions Aortic Dissection, Inflammation
Enrollment 1,346 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov