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

(BASA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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

Prior Safety Data

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

Trial 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 (Antiplatelet Agent)
• Aspirin 81 mg (Antiplatelet Agent)

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, Australia 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

🇦🇺 Approved in Australia as Aspirin for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Loma Linda University Medical Center Loma Linda, CA

Who Is Running the Clinical Trial?

Loma Linda University Lead Sponsor

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] Although therapy with acetylsalicylic acid (aspirin, ASA) is well established in secondary prevention of stroke, efficacy and side effects of this substance in acute stroke treatment are undetermined. ASA may be useful in acute cerebral ischemia because of its potential to prevent thrombus propagation and neuronal damage. A total of 268 patients with an acute cerebral ischemia, who were admitted to our stroke unit within 24 hours after stroke, were treated with intravenously administered ASA (0.5 g/day) in combination with low-dose heparin. The functional status of the patients was assessed after 1 month using the modified Rankin Scale. Eighteen (6.7%) patients died during the observation period. The functional status according to Rankin Scale was classified as stage 0 in 76 (28.3%), 1 in 59 (22.0%), 2 in 39 (14.6%), 3 in 32 (12.3%), 4 in 36 (13.4%), and 5 in 7 (2.6%) patients. A symptomatic secondary intracerebral hemorrhage was seen in one patient. Gastrointestinal symptoms were observed in 13 (4.8%) patients, including five instances of gastrointestinal bleeding. Further complications were allergic reactions to aspirin (one) and hematuria (one). Recurrent cerebral ischemia occurred in nine (3.3%) patients (five with transient ischemic attack or minor stroke) during the observation period. We conclude that treatment of acute ischemic stroke with intravenously applied aspirin in combination with low-dose heparin is safe. Efficacy of this therapy should be elucidated in a controlled trial.

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

The dose of aspirin for the prevention of cardiovascular and cerebrovascular events. [2019] Low dose aspirin (ASA) (75-325 mg daily) is commonly used for the secondary prevention of cardiovascular and cerebrovascular events, as recommended by US national guidelines. Questions remain, however, as to whether there is a difference in the efficacy and safety across this low dose range.

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

Management of Extracranial Blunt Cerebrovascular Injuries: Experience with an Aspirin-Based Approach. [2022] Optimal management of patients with extracranial blunt cerebrovascular injury (BCVI) remains controversial, with both anticoagulation and antiplatelet therapy being recommended. The purpose of this study was to evaluate the efficacy and safety of using acetylsalicylic acid (ASA) in the management of BCVI.

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] Perioperative low-dose aspirin (ASA) management for open craniotomy surgery lacked information. We analyze to establish the perioperative ASA strategy to minimize both hemorrhagic and thromboembolic complications.

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] We sought to compare the risk of hemorrhage due to the low (200 mg) doses of aspirin (acetylsalicylic acid [ASA]) in 192,036 patients enrolled in 31 clinical trials. Despite substantial differences in the reporting patterns of bleeding complications, low-dose ASA was associated with the lowest risk, and moderate doses caused a relatively high hemorrhagic event rate, especially with regard to minor, gastrointestinal, and total bleeding, and stroke. These findings should be considered when using combination antiplatelets, anticoagulant therapy, or both, with ASA, especially with the daily dose of >100 mg.

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] Acetylsalicylic acid (ASA) is a well-known and widely used analgesic for acute pain. Patients with acute headache due to subarachnoid hemorrhage (SAH) are inclined to take ASA in this situation. Due to the antithrombotic effects, ASA intake is related to higher bleeding rates in case of hemorrhage or surgical treatment. Between January 2006 and December 2016, 941 patients without continuous antithrombotic or anticoagulant medication were treated due to SAH in our institution. Fourteen of them (1.5%) had taken ASA as a single dose because of headache within 24 h before hospital admission. A matched pair analysis was performed. Admission status was good in 93% of patients with one-time use of ASA (OTA), but only in 59% of all other patients (p

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] We prospectively analyzed adverse effects of aspirin in a multicentered cooperative study undertaken to determine the role of endarterectomy in the treatment of asymptomatic carotid artery stenosis. Persons with active peptic ulcer disease or known intolerance to aspirin were excluded from the study. Patients initially received 650 mg aspirin twice daily. After a 54-month recruitment period, 444 patients in 11 centers were followed up for as many as 8 years (mean 47.9 +/- 27.9 months). Patients intolerant to 650 mg aspirin twice daily could be switched to enteric-coated aspirin or "low-dose" aspirin (80 to 325 mg daily). At the conclusion of the study, we performed a cross-sectional analysis of aspirin usage and complications. Overall, there were 757 episodes reported wherein adjustments in study medications were made, including cessation and change in formulation or dosage. At the conclusion of the study, at the time of death, or at occurrence of a neurologic end point, 16% of patients were off medication entirely, 51% had been converted to enteric-coated aspirin, and only 33% were taking regular aspirin with 27% of those having been placed on a reduced dosage. Adverse reactions were ascertained from 4954 patient visit records. In all there were a total of 837 adverse reactions reported, or one in every 5.9 visits. The most frequently reported reaction was heartburn or stomach pain for which 372 episodes were reported in 184 (42%) patients. Nausea or vomiting occurred on 79 occasions in 58 patients, and bloody stools were reported 52 times in 41 patients. We conclude that high-dose aspirin therapy for asymptomatic carotid artery stenosis is poorly tolerated and that adverse reactions even to low-dose enteric-coated aspirin are common even in patients screened for aspirin intolerance.

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] Platelet aggregation and bleeding time was measured in 43 cerebrovascular patients participating in a controlled double-blind study of low-dose acetylsalicylic acid. In 19 patients with satisfactory inhibition of the platelet aggregation obtained by 50 to 70 mg acetylsalicylic acid per day the bleeding time averaged 11.2 minutes in contrast to 7.0 minutes in the placebo group, p less than 0.001. This study confirms our previous findings of platelet inhibition by low-dose acetylsalicylic acid in patients with cerebrovascular disease. The prolongation of the bleeding time demonstrates that we are dealing not merely with an in vitro phenomenon but with a significant in vivo effect. The study provides the rationale for clinical evaluations of low-dose acetylsalicylic acid in stroke prophylaxis.