NCT07205250

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

Not yet recruiting EARLY_PHASE1 Last updated 12 February 2026

What this trial tests

EARLY_PHASE1 trial testing enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) in Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm in 224 participants. Not yet recruiting.

Timeline

20 February 2026

Primary endpoint
20 January 2028

20 September 2028

Quick facts

Lead sponsor	The General Hospital of Western Theater Command
Phase	EARLY_PHASE1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	224
Start date	20 February 2026
Primary completion	20 January 2028
Estimated completion	20 September 2028

Drugs / interventions tested

• enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) — full drug profile →
• a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets

Conditions studied

• Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm — all drugs for Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm →

Sponsor

The General Hospital of Western Theater Command

Who can join

18 and older, any sex, with Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.