Low-Dose vs Standard-Dose Aspirin for Head/Neck Vessel Injury

(BASA Trial)

Overseen By Sina Asaadi, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Loma Linda University

Must be taking: Aspirin

Must not be taking: Heparin, Anticoagulants, Anti-Platelets

Disqualifiers: Pregnancy, Acute stroke, Spinal trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of Aspirin can prevent strokes in individuals with injuries to head and neck blood vessels. It compares a low dose (81 mg) with a standard dose (325 mg) to determine which is more effective and whether either causes fewer bleeding issues. Suitable participants have been diagnosed with blunt cerebrovascular injury (injuries to blood vessels in the head or neck) using a special scan called a CTA. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on Heparin or other full-dose anticoagulants, or if you are taking anti-platelet medications other than Aspirin.

What is the safety track record for these treatments?

Research has shown that both low-dose and standard-dose aspirin are generally safe for preventing strokes in individuals with head and neck blood vessel injuries. Studies have found that taking 81 mg of aspirin can reduce the stroke rate to about 3.5%, indicating its safety for stroke prevention. People with multiple injuries who took low-dose aspirin also required fewer surgeries and had lower death rates.

For 325 mg aspirin, while specific numbers aren't available, it is often used for similar conditions, suggesting comparable safety. Generally, both aspirin doses are well-tolerated, but there is a risk of bleeding, which is important to consider when selecting a dose. Concerns about side effects should be discussed with a doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using different doses of aspirin for head and neck vessel injuries because it offers a potentially safer and more effective treatment option. Unlike many standard treatments that primarily focus on higher doses or surgical interventions, this approach evaluates the benefits of both low-dose (81 mg) and standard-dose (325 mg) aspirin. Aspirin works by reducing blood clot formation, which could prevent complications in vessel injuries. By comparing these two doses, researchers aim to determine if a lower dose can provide the same benefits with possibly fewer side effects, which could be a game-changer in managing such injuries.

What evidence suggests that this trial's treatments could be effective for preventing strokes in patients with head and neck vessel injury?

Research shows that a low dose of Aspirin (81 mg), which participants in this trial may receive, can help prevent strokes in people with blunt injuries to the blood vessels in the head and neck. Studies have found that this dose results in a stroke rate as low as 3.5%. A higher dose of Aspirin (325 mg) is another treatment option in this trial and has also been used for stroke prevention in similar situations, though current research does not clearly detail the exact stroke rates for this dose. This trial compares both doses to determine which one is more effective while causing fewer side effects. Overall, Aspirin is known to lower the risk of stroke in patients with these types of blood vessel injuries. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with blunt cerebrovascular injury confirmed by a CT scan. It's not for those who've had an acute stroke, are under 18, pregnant, lack a way to take oral medication, use other anti-platelets or full anticoagulants at diagnosis, have the most severe BCVI grade or any Aspirin allergy.

Inclusion Criteria

All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission

Exclusion Criteria

I have a grade 5 blood vessel injury in my brain.

I am under 18 years old.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Aspirin 81 mg or Aspirin 325 mg daily to evaluate stroke prevention efficacy and rate of hemorrhagic complications

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and bleeding incidence

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin 325 mg
• Aspirin 81 mg

Trial Overview The study compares low-dose (81 mg) and regular-dose (325 mg) Aspirin to see which is better at preventing strokes in patients with head and neck vessel injuries without increasing bleeding risks.

How Is the Trial Designed?

Group I: Oral Daily Aspirin 81 mg Active Control 1 Intervention

Group II: Oral Daily Aspirin 325 mg Active Control 1 Intervention

Aspirin 325 mg is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Stroke prevention

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Stroke prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Stroke prevention

Approved in Japan as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Stroke prevention

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

In a study of 94 patients with extracranial blunt cerebrovascular injury (BCVI), acetylsalicylic acid (ASA) was found to be an effective primary treatment, with 94% of patients showing stable or improved vascular conditions after a mean follow-up of 36 days.

While ASA treatment was associated with some complications (7% of patients), including cases of intracranial hemorrhage and gastrointestinal bleeding, the overall safety profile suggests that ASA could be a preferred management strategy for BCVI, pending further confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Extracranial Blunt Cerebrovascular Injuries: Experience with an Aspirin-Based Approach. Catapano, JS., Israr, S., Whiting, AC., et al.[2022]

In a study of 444 patients over an average of 48 months, high-dose aspirin (650 mg twice daily) was found to be poorly tolerated, with 16% of patients stopping the medication entirely due to adverse effects.

Common adverse reactions included heartburn or stomach pain (42% of patients), nausea or vomiting, and bloody stools, indicating that even low-dose enteric-coated aspirin can lead to significant gastrointestinal issues in patients, despite screening for intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of aspirin in the treatment of asymptomatic carotid artery stenosis. The VA Cooperative Asymptomatic Carotid Artery Stenosis Study Group. Krupski, WC., Weiss, DG., Rapp, JH., et al.[2019]

In a study of 192,036 patients across 31 clinical trials, low-dose aspirin (<100 mg) was found to have the lowest risk of hemorrhage compared to moderate (100-200 mg) and high (>200 mg) doses.

Moderate doses of aspirin were associated with a higher rate of bleeding complications, particularly minor and gastrointestinal bleeding, highlighting the need for caution when combining aspirin with other antiplatelet or anticoagulant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of risk of bleeding complications after different doses of aspirin in 192,036 patients enrolled in 31 randomized controlled trials. Serebruany, VL., Steinhubl, SR., Berger, PB., et al.[2022]

A review of studies indicates that low dose aspirin (75-325 mg) does not show significant differences in safety across this range, with no increased bleeding events reported in randomized controlled trials.

Aspirin 325 mg daily may be at least as effective as 75 mg daily for preventing cardiovascular and cerebrovascular events, suggesting that higher doses could be considered based on individual patient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dose of aspirin for the prevention of cardiovascular and cerebrovascular events. Fisher, M., Knappertz, V.[2019]

Continuing low-dose aspirin (ASA) during the perioperative period for open craniotomy surgery increased the risk of postoperative intracranial hemorrhage, particularly in patients with older age, multiple aneurysms, and larger aneurysms.

Discontinuing ASA was linked to a higher risk of major cardio- and cerebrovascular events (MACCEs) in patients who were in secondary prevention, suggesting that early resumption of ASA is beneficial if there is no evidence of hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Low-Dose Aspirin Management for Planned Clipping Surgery: When, How Long, and With What Precautions? Han, HJ., Kim, J., Jang, CK., et al.[2023]

In a study of 268 patients with acute cerebral ischemia treated with intravenous aspirin and low-dose heparin, the treatment was found to be safe, with only one case of symptomatic secondary intracerebral hemorrhage and a low incidence of gastrointestinal complications.

While the functional outcomes varied, with 28.3% of patients achieving a Rankin Scale score of 0 (no symptoms), the efficacy of this treatment needs further investigation in controlled trials to determine its effectiveness in acute stroke management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenously administered acetylsalicylic acid in combination with low-dose heparin in acute ischemic stroke: a safety analysis. Büttner, T., Hellwig, K., Müller, T., et al.[2013]

In a study of 43 cerebrovascular patients, low-dose acetylsalicylic acid (50 to 70 mg per day) significantly inhibited platelet aggregation, confirming its effectiveness in vivo.

Patients receiving acetylsalicylic acid had a prolonged bleeding time (11.2 minutes) compared to the placebo group (7.0 minutes), indicating a meaningful impact on blood clotting that supports its use in stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolongation of bleeding time and inhibition of platelet aggregation by low-dose acetylsalicylic acid in patients with cerebrovascular disease. Boysen, G., Boss, AH., Odum, N., et al.[2019]

In a study of 941 patients with subarachnoid hemorrhage (SAH), only 1.5% had taken a single dose of acetylsalicylic acid (ASA) before admission, and these patients had a significantly better admission status (93% good condition) compared to those who did not take ASA (59%).

Patients who took ASA showed no difference in bleeding patterns or complications during aneurysm treatment, and most achieved favorable outcomes after 6 months, suggesting that ASA use does not negatively impact treatment decisions in SAH cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain medication at ictus of subarachnoid hemorrhage-the influence of one-time acetylsalicylic acid usage on bleeding pattern, treatment course, and outcome: a matched pair analysis. Bruder, M., Kashefiolasl, S., Keil, F., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05868525

Stroke Rate in Patients With Blunt Cerebrovascular Injury ... The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624000918

Stroke Prevention in Blunt Cerebrovascular Injury We investigated the efficacy and safety of oral Aspirin (ASA) 81 mg to prevent BCVI-related stroke compared to historically reported stroke rates with ASA 325 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38492727/

Stroke Prevention in Blunt Cerebrovascular Injury We investigated the efficacy and safety of oral Aspirin (ASA) 81 mg to prevent BCVI-related stroke compared to historically reported stroke ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8076921/

Treatment of asymptomatic blunt cerebrovascular injury ... The aim of this systematic review was to determine if a specific treatment results in lower stroke rates and/or improved vessel healing in asymptomatic BCVI.

5. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(24)00091-8/fulltext

Stroke Prevention in Blunt Cerebrovascular Injury Stroke prevention in blunt cerebrovascular injury using Aspirin 81 mg was promising. The stroke rate with Aspirin 81 mg was as low as 3.5%.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/492855

Stroke Rate in Patients With Blunt Cerebrovascular Injury ... The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with ...