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

Trial Summary

What is the purpose of this trial?

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 vessels injury. The main questions it aims to answer are: * If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower than and Aspirin 325 mg. * If rate of hemorrhagic complications in patients with head and neck vessels injury taking Aspirin 81 mg is not higher than patients that take Aspirin 325 mg.

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 data supports the effectiveness of the drug for head/neck vessel injury?

Aspirin (ASA) is commonly used in low doses (75-325 mg daily) for preventing cardiovascular and cerebrovascular events, which suggests it may help in managing head/neck vessel injuries by reducing the risk of blood clots. ^{1 2 3 4 5}

Is aspirin generally safe for humans?

Aspirin (acetylsalicylic acid, ASA) is generally safe for humans, but it can increase the risk of bleeding, especially at higher doses. Low-dose aspirin is associated with a lower risk of bleeding compared to moderate doses. Some people may experience gastrointestinal symptoms or allergic reactions. ^{1 2 3 5 6}

How does aspirin differ from other drugs for head/neck vessel injury?

This trial compares low-dose (81 mg) and standard-dose (325 mg) aspirin, which is unique because aspirin is commonly used for preventing blood clots and reducing inflammation, but its specific use for head/neck vessel injury is less established. The study aims to determine the optimal dose for safety and effectiveness in this condition, which is not well-defined in current treatments. ^{1 2 3 7 8}

Eligibility Criteria

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

I am 18 years old or older.

Exclusion Criteria

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

I am under 18 years old.

Pregnant women

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intravenously administered acetylsalicylic acid in combination with low-dose heparin in acute ischemic stroke: a safety analysis. [2013]

2. England pubmed.ncbi.nlm.nih.gov

The dose of aspirin for the prevention of cardiovascular and cerebrovascular events. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Management of Extracranial Blunt Cerebrovascular Injuries: Experience with an Aspirin-Based Approach. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative Low-Dose Aspirin Management for Planned Clipping Surgery: When, How Long, and With What Precautions? [2023]

5. United States 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. [2022]

6. Germany 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. [2020]

7. United States 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. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Prolongation of bleeding time and inhibition of platelet aggregation by low-dose acetylsalicylic acid in patients with cerebrovascular disease. [2019]