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 | 360 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 360 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 360 patients with Stanford Type A aortic dissection, conducted between 2025 and 2027. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] preoperatively and 30 mg twice daily \[BID\] 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: * Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery. Aged between 18 and 65 years. Signed informed consent. Exclusion Criteria: * Patients who are unable to eat independently or require prolonged fasting. History of malignant tumors. Body weight \<50 kg. Traumatic aortic dissection. Patients with Marfan syndrome. Unstable vital signs requiring preoperative mechanical support or resuscitation (e.g., IABP \[Intra-Aortic Balloon Pump\], ECMO \[Extracorporeal Membrane Oxygenation\], LVAD \[Left Ventricular Assist Device\]) Patients requiring preoperative endotracheal intubation. Consciousness impairment, central nervous system dysfunction, or evidence of cerebral malperfusion syndrome upon admission. Preoperative hematemesis, melena, fresh blood in stool, or symptoms of bowel dilation. Clear evidence of limb malperfusion before surgery. Presence of organ malperfusion syndrome. Patients requiring interventional procedures to relieve organ malperfusion before surgery. History of gastrointestinal ulcers or chronic gastrointestinal inflammatory diseases. History of dialysis or renal insufficiency before admission. History of liver disease. Allergy to ketorolac tromethamine, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Chronic inflammatory diseases, autoimmune diseases, or long-term use of steroids or NSAIDs for other reasons. Absence of cerebral perfusion during deep hypothermic circulatory arrest. History of major surgery or acute myocardial infarction within 90 days. History of cardiac or major vascular surgery. Pregnant or lactating women. Patients who refuse to participate in this clinical trial or decline to sign the informed consent form. Any other conditions deemed unsuitable for participation by the investigator.
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 360 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 360 participants.