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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
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 30 day after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to 30 day after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of patients that experienced any Aspirin-related adverse events
Rate of any bleeding incidence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
315 Previous Clinical Trials
266,492 Total Patients Enrolled

Media Library

Aspirin 325 mg (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05868525 — Phase 4
Blunt Cerebrovascular Injury Research Study Groups: Oral Daily Aspirin 81 mg, Oral Daily Aspirin 325 mg
Blunt Cerebrovascular Injury Clinical Trial 2023: Aspirin 325 mg Highlights & Side Effects. Trial Name: NCT05868525 — Phase 4
Aspirin 325 mg (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868525 — Phase 4
~65 spots leftby Dec 2025
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