NCT06968806 Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
| NCT ID | NCT06968806 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,346 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,346 participants in total. It began in 2025-10-27 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria The criteria for inclusion are: (1) Imaging diagnosis of ATAAD and planning for emergency surgery; (2) Age between 18 and 65 years; (3) Signed informed consent; (4) First median sternotomy; (5) Duration from symptom onset to surgery less than or equal to 7 days; (6) Preoperative data are complete; (7) Glasgow Coma Scale (GCS) score greater than or equal to 15, with no new focal neurological deficits. Exclusion criteria The criteria for exclusion include: (1) Extended periods of fasting or inability to feed oneself; (2) A history of cancer; (3) Weight below 50 kg; (4) Traumatic dissections of the aorta; (5) Individuals diagnosed with Marfan syndrome; (6) Preoperative vital sign instability necessitating mechanical assistance or resuscitation ; (7) The duration of preoperative tracheal intubation exceeds 3 days. (8) Disorders of consciousness, central nervous system issues, or signs of inadequate brain perfusion after admission; (9) Preoperative gastrointestinal involvement and intestinal dilation； (10) Clear signs of inadequate limb perfusion before the procedure; (11) Presence of organ perfusion insufficiency syndrome; (12) Patients needing preliminary surgical intervention to address organ perfusion issues; (13) A history of gastrointestinal ulcers or chronic inflammation of the gastrointestinal tract;;(14) Preoperative hepatic and renal dysfunction;(15) Allergies to ketorolac tromethamine, aspirin, or other NSAIDs; (16) Chronic inflammatory or autoimmune conditions requiring long-term hormone or NSAID use; (17) Absence of brain perfusion during deep hypothermic circulatory arrest; (18) A history of grade IV surgery or acute myocardial infarction within the last 90 days; (19) Previous cardiac or major vascular surgeries; (20) Pregnant or breastfeeding women; (21) Cardiopulmonary bypass (CPB) lasting over 4 hours, deep hypothermic circulatory arrest (DHCA) exceeding 40 minutes, or total surgical time over 10 hours; (22) Any other conditions considered inappropriate for participation by the researchers.
Contact & Investigator
Tuo Pan, MD
STUDY DIRECTOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Frequently Asked Questions
Who can join the NCT06968806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06968806 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,346 participants.
Is NCT06968806 currently recruiting?
Yes, NCT06968806 is actively recruiting participants. Contact the research team at pan_tuo@126.com for enrollment information.
Where is the NCT06968806 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06968806 clinical trial?
NCT06968806 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Tuo Pan, MD at The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 1,346 participants.