Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA). (BASA)

January 28, 2026 updated by: Loma Linda University

Pilot, Non-masked, Randomized Clinical Trial for Evaluation of Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maryam B Tabrizi, M.D
  • Phone Number: (909) 558-4286
  • Email: MTabrizi@llu.edu

Study Contact Backup

  • Name: Sina Asaadi, M.D
  • Phone Number: (412) 539-7088
  • Email: sasaadi@llu.edu

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18
  • All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission

Exclusion Criteria:

  • Age <18
  • Pregnant women
  • No enteral route access for Aspirin administration
  • Patients who are on Heparin drip or other full dose anticoagulation when BCVI diagnosed
  • Patients who are on other Anti-Platelets aside from Aspirin when BCVI diagnosed
  • Patients with BCVI grade 5 injury based on Biffl classification
  • Presence of any contraindication or history of allergy to Aspirin
  • Patient with the diagnosis of acute stroke at the time of BCVI diagnosis matching the injured vessel territory on imaging
  • Patients with acute spinal trauma that needs surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Daily Aspirin 81 mg
Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab
Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.
Active Comparator: Oral Daily Aspirin 325 mg
Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab
Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Time Frame: From randomization up to 3 months after discharge
From randomization up to 3 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients that experienced any Aspirin-related adverse events
Time Frame: From randomization up to 3 months after discharge
An allergic reaction or gastrointestinal bleeding
From randomization up to 3 months after discharge
Rate of need for bleeding control operations/interventions in patients with solid organ injury
Time Frame: From randomization up to 30 day after randomization
From randomization up to 30 day after randomization
Need for blood product transfusion
Time Frame: From randomization up to 30 day after randomization
From randomization up to 30 day after randomization
Rate of any bleeding incidence
Time Frame: From randomization up to 30 day after randomization
major or minor bleeds define according to the International Society of Thrombosis and Hemostasis (ISTH)
From randomization up to 30 day after randomization
Number of patients that experienced any incidence of worsening brain hemorrhage
Time Frame: From randomization up to 30 day after randomization
From randomization up to 30 day after randomization
Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
Time Frame: From randomization up to 3 months after discharge
From randomization up to 3 months after discharge
Change in severity of the neck and head vessels injury based on Biffl grading scale
Time Frame: From randomization up to 3 months after discharge
From randomization up to 3 months after discharge
In-hospital mortality rate
Time Frame: From randomization up to 30 day after randomization
From randomization up to 30 day after randomization
Out-patient mortality rate
Time Frame: From discharge up to 3 months after discharge
From discharge up to 3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5220429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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