Recruiting

ASA 81 mg vs. ASA 325 mg

Sponsor:

Loma Linda University

Code:

NCT05868525

Conditions

Blunt Cerebrovascular Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aspirin 325Mg Tab, Aspirin 81Mg Tab

Study Details

Brief summary:

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.

Conditions

Blunt Cerebrovascular Injury

Study ID

NCT05868525

Start date

Aug 23, 2023

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Oral Daily Aspirin 81 mg

active comparator: Oral Daily Aspirin 325 mg

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Maryam B Tabrizi, M.D

(909) 558-4286MTabrizi@llu.edu

Sina Asaadi, M.D

(412) 539-7088sasaadi@llu.edu

Locations

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Maryam Tabrizi, M.D

904-576-5045Mtabrizi@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Blunt cerebrovascular injury
  • BCVI
  • Carotid artery
  • Vertebral Artery
  • Internal Carotid Artery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-01-30.