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Antiplatelet Agent
Low-Dose vs Standard-Dose Aspirin for Head/Neck Vessel Injury (BASA Trial)
Phase 4
Recruiting
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 30 day after randomization
Awards & highlights
BASA Trial Summary
This trial will compare Aspirin 81 mg and 325 mg to see if one is better at preventing strokes in those with head/neck vessel injury, with an eye to any increased risk of bleeding.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include gastrointestinal issues like stomach pain and bleeding, allergic reactions, increased risk of bruising or bleeding elsewhere if injured.
BASA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to 30 day after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 30 day after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Secondary outcome measures
Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
Change in severity of the neck and head vessels injury based on Biffl grading scale
In-hospital mortality rate
+6 moreBASA Trial Design
2Treatment groups
Active Control
Group I: Oral Daily Aspirin 81 mgActive Control1 Intervention
Group II: Oral Daily Aspirin 325 mgActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,886 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a grade 5 blood vessel injury in my brain.I am under 18 years old.I was diagnosed with a stroke that matches the area affected by my vessel injury.I am on a full dose of anticoagulation therapy since my blood vessel injury diagnosis.I cannot take Aspirin by mouth.I am taking anti-platelet medication other than aspirin.I am 18 years old or older.I need surgery for a recent spinal injury.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Daily Aspirin 81 mg
- Group 2: Oral Daily Aspirin 325 mg
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications being accepted for this research project at present?
"As per the information on clinicaltrials.gov, this trial is actively enrolling patients. The initial posting date was November 1st 2023 and had its last update on August 23rd 2023."
Answered by AI
Are there any substantial risks associated with taking 81 mg of Oral Daily Aspirin?
"As this is a Phase 4 trial, meaning the drug has been approved for use, our team at Power rated Oral Daily Aspirin 81 mg as having a safety score of 3."
Answered by AI
What is the upper participant limit of this investigation?
"Affirmative. Clinicaltrials.gov has the trial listed as open to participants since November 1st, 2023 and was updated on August 23rd, 2023. The team behind this research is currently looking for 98 people to take part at a single site."
Answered by AI
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