Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic AneurysmEarly Phase 1NCT07205250
Aspirin for Prevention of Stroke After Endovascular Aortic Arch Repair: a Multicenter, Double-Blind, Randomized Controlled Trial
A Early Phase 1 study testing enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) in people with Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm, run by The General Hospital of Western Theater Command.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm
- What is being tested?
- enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 20 Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: WesternTheaterCommand
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.
Read more
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.
- Being tested
- enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet), a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tablets
- Keywords
- aspirin; stroke; endovascular aortic arch repair; prevention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)Drug
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 investigational drug for 6 months followed by placebo for 6 months; Aspirin 1-year will receive the investigational drug for 1 year).
a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tabletsOther
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 tablets used in the study).
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 3-month group | Experimental | Patients in the Aspirin 3-month 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 three months.Then receive placebo treatment for nine months. Receives: 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 |
| Aspirin 6-month group | Experimental | Patients in the Aspirin 6-month 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.Then receive placebo treatment for six months. Receives: 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 |
| Aspirin 1-year group | Experimental | Patients in the Aspirin 1-year 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 one year. Receives: Drug: enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative stroke.
yes or no
Measured: After one year
Secondary outcomes (4)
Patency rate of reconstructed branch vessels,
yes or no
Measured: After one year
incidence of major postoperative bleeding complications,
yes or no
Measured: After one year
incidence of complications related to endovascular aortic arch repair (e.g., thrombosis, bleeding, infection),
yes or no
Measured: After one year
incidence of postoperative cognitive impairment.
yes or no
Measured: After one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start20 Feb 2026 (estimated)
- Primary completion20 Jan 2028 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, double-blind, randomized, placebo-controlled, parallel-group clinical trial. Using a parallel-group design, participants are randomly assigned to one of three groups: three aspirin groups with different treatment durations (3 months, 6 months, 1 year). For the three-month and six-month aspirin groups, placebo administration will be maintained after completing the assigned treatment duration. All three groups proceed with the intervention concurrently. The study uses pre-defined efficacy endpoints to measure and evaluate outcomes synchronously.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, siyi He, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205250
- Sponsor's protocol ID
- hesiyi WesternTheaterCommand
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WesternTheaterCommand
- ClinicalTrials.gov ID
- NCT07205250
- Acronym / sponsor ID
- hesiyi WesternTheaterCommand
- Keywords
- aspirin; stroke; endovascular aortic arch repair; prevention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a multicenter, double-blind, randomized, placebo-controlled, parallel-group clinical trial. Using a parallel-group design, participants are randomly assigned to one of three groups: three aspirin groups with different treatment durations (3 months, 6 months, 1 year). For the three-month and six-month aspirin groups, placebo administration will be maintained after completing the assigned treatment duration. All three groups proceed with the intervention concurrently. The study uses pre-defined efficacy endpoints to measure and evaluate outcomes synchronously.
| Arm | Type | Receives |
|---|---|---|
| Aspirin 3-month group | Experimental | 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 tabletsPatients in the Aspirin 3-month 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 three months.Then receive placebo treatment for nine months. |
| Aspirin 6-month group | Experimental | 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 tabletsPatients in the Aspirin 6-month 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.Then receive placebo treatment for six months. |
| Aspirin 1-year group | Experimental | Drug: enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet)Patients in the Aspirin 1-year 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 one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 investigational drug for 6 months followed by placebo for 6 months; Aspirin 1-year will receive the investigational drug for 1 year). | Drug | Aspirin 1-year group, Aspirin 3-month group, Aspirin 6-month group |
| a placebo with identical or similar appearance, taste, smell, and packaging to the aspirin tabletsThe 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 tablets used in the study). | Other | Aspirin 3-month group, Aspirin 6-month group |
Primary outcome
Incidence of postoperative stroke.
Time frame: After one year
yes or no
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing enteric-coated aspirin tablets (100 mg once daily, Bayer Healthcare, specification: 100 mg/tablet) in people with Type B or Non-A Non-B Aortic Dissection;Thoracic Aortic Aneurysm, run by The General Hospital of Western Theater Command.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SiYi HE, MD (86-13558837339, hesiyi@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative stroke. (time frame: After one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.