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

Wei Wu

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm

Treatments: Drug: enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet); Other: a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT07205250

WWWesternTheaterCommand

Details and patient eligibility

About

Abstract Introduction: Endovascular aortic arch repair (EAAR) and endovascular reconstruction of arch branch vessels have emerged as a new trend in treating aortic arch pathologies due to their advantages of minimal invasiveness, faster recovery, and fewer complications. Stroke is a common and severe complication during EAAR procedures; however, preventive strategies and the necessity of postoperative antiplatelet therapy remain unreported.

Methods and analysis: This project aims to conduct a prospective, multicenter, double-masked randomized controlled study. Patients undergoing EAAR will be randomly assigned to either an aspirin or a placebo group, receiving six months of aspirin or placebo treatment postoperatively. Both groups will be followed up for over one year, with the primary outcome being the incidence of postoperative stroke. Secondary outcomes include the patency rate of reconstructed branch vessels, the incidence of major bleeding complications, EAAR-related complications, and postoperative cognitive impairment. The study will evaluate the efficacy and safety of aspirin in preventing stroke after EAAR.

Furthermore, through stratified analysis, the study will explore the impact of different reconstruction techniques, the number of reconstructed branch arteries, and the diameter of branch stents on postoperative stroke rates. It will also assess the value of aspirin in different subgroups, aiming to provide more precise clinical strategies for prevention and treatment.

Ethics and dissemination:（Mandatory pre-implementation review by the Institutional Review Board (IRB) of Western Theater Command General Hospital ensures full compliance with national ethical standards and regulatory requirements.

All research personnel must adhere strictly to ethical principles and assume full accountability for protecting participant rights and monitoring ongoing safety. The trial's results will be disseminated through academic conferences and journal publications.

Enrollment: 538 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Adult patients aged 18 years or older;
2. 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;
3. Underwent total endovascular aortic arch repair at the participating center with concurrent intraoperative endovascular reconstruction of supra-arch branch arteries;
4. Signed the informed consent form and agreed to participate in this randomized controlled trial.

Exclusion Criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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538 participants in 2 patient groups, including a placebo group

the aspirin tablets1

Experimental group

Description:

Patients will be randomly divided into two groups: the aspirin group and the placebo group. Patients in the aspirin group will begin oral administration of enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) on the first postoperative day. The oral medication course will last for six months.

Treatment:

Drug: enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)

the aspirin tablets2

Placebo Comparator group

Description:

Patients in the placebo group will receive a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets. The oral medication course will last for six months.

Treatment:

Other: a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets