Aspirin for Prevention of Stroke After Endovascular Aortic Arch Repair: a Multicenter, Double-Blind, Randomized Controlled Trial

Official title

WesternTheaterCommand

Overview

ABSTRACT Introduction Endovascular aortic arch repair (EAAR) and the endovascular reconstruction of arch branch vessels represent a new trend in managing aortic arch pathologies, due to advantages such as minimal invasiveness, rapid recovery, and fewer complications. However, stroke is a common and serious complication during EAAR procedures. Strategies for its prevention, including the question of whether antiplatelet therapy should be administered postoperatively, have not yet been reported. Methods and analysis This project is designed as a prospective, multicenter, double-blind, randomized controlled trial. Patients undergoing Endovascular Aortic Arch Repair (EAAR) will be randomly assigned to three groups: aspirin treatment for 3 months, 6 months, or 1 year. All three groups will be followed up on for over one year. The primary endpoint is the incidence of postoperative stroke, while secondary endpoints include the patency rate of reconstructed supra-aortic branches, the incidence of major bleeding complications, EAAR-related complications, and the incidence of postoperative cognitive impairment. The study aims to evaluate the efficacy and safety of aspirin in preventing stroke after EAAR. Furthermore, stratified analyses will be conducted based on factors such as reconstruction techniques, the number of reconstructed branch arteries, and the diameter of branch stents to explore their impact on stroke incidence post-EAAR. The clinical utility of aspirin in different subgroups will also be assessed to provide more precise and personalized treatment strategies for clinical practice. Ethics and dissemination This study has been approved by the Western Theater Command General Hospital and will be conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval has been obtained separately from all participating research centers. STRENGTHS AND LIMITATIONS OF THIS STUDY Endovascular aortic arch repair (EAAR) and endovascular reconstruction of the aortic arch branches have emerged as a new trend in managing aortic arch pathologies, owing to advantages such as minimal invasiveness, rapid recovery, and fewer complications. Stroke is a common and serious complication during EAAR procedures; however, strategies for its prevention, including the need for postoperative antiplatelet therapy, have not been well documented. This project aims to conduct a prospective, multicenter randomized controlled trial to evaluate the efficacy and safety of aspirin in preventing stroke following EAAR, thereby providing evidence for clinical decision-making and improving long-term patient outcomes. As the trial will be conducted in China, where the population is predominantly Han Chinese, the generalizability of the findings may be limited.

Interventions

• Drug enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)
  Patients are randomized into three groups using a random number table or lottery method: Aspirin 3-month group, Aspirin 6-month group, Aspirin 1-year group. Every group begin oral administration of aspirin enteric-coated tablets 100 mg once daily (qd) (Bayer Healthcare Co., Ltd., specification: 100 mg/tablet) on the first postoperative day. Aspirin 3-month group will receive the investigational drug for 3 months followed by placebo for 9 months; Aspirin 6-month group will receive the investigati
• Other a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets
  The placebo's smell, color, taste, and packaging are identical or very similar to the aspirin enteric-coated tablets (Shandong Xinhua Pharmaceutical Co., Ltd., one of the world's largest producers of aspirin API and finished dosage forms. The company has extensive tablet manufacturing experience and GMP certification. Specifications regarding the appearance \[size, color, shape\], weight, taste, etc., of the placebo have been clearly defined to ensure it is completely identical to the aspirin ta

Primary outcome measures

• Incidence of postoperative stroke. [Time frame: After one year]

Secondary outcome measures (4)

• Patency rate of reconstructed branch vessels, [Time frame: After one year]
• incidence of major postoperative bleeding complications, [Time frame: After one year]
• incidence of complications related to endovascular aortic arch repair (e.g., thrombosis, bleeding, infection), [Time frame: After one year]
• incidence of postoperative cognitive impairment. [Time frame: After one year]

Eligibility criteria

Inclusion criteria

• Adult patients aged 18 years or older;
• Diagnosed with type B or non-A non-B aortic dissection or thoracic aortic aneurysm according to the 2022 Chinese Expert Consensus on Stanford Type B Aortic Dissection;
• Underwent total endovascular aortic arch repair at the participating center with concurrent intraoperative endovascular reconstruction of supra-arch branch arteries;
• Signed the informed consent form and agreed to participate in this randomized controlled trial.

Exclusion criteria

• Patients with known allergies to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• Patients with bleeding tendencies or active bleeding;
• Patients who used medications affecting coagulation (e.g., warfarin, antiplatelet drugs) within 30 days before surgery;
• Patients with a history of stroke;
• Patients undergoing concurrent additional surgical procedures during the operation;
• Patients with severe multi-organ dysfunction or other critical illnesses;
• Patients unable to comply with study protocols or complete postoperative follow-up;
• Patients participating in other drug or clinical studies that may interfere with the results of this research.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07205250 · hesiyi WesternTheaterCommand

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗