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

Loma Linda University (LLU) logo

Loma Linda University (LLU)

Status and phase

Enrolling
Phase 4

Conditions

Blunt Cerebrovascular Injury

Treatments

Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab

Study type

Interventional

Funder types

Other

Identifiers

NCT05868525
5220429

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

Oral Daily Aspirin 81 mg
Active Comparator group
Treatment:
Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab
Oral Daily Aspirin 325 mg
Active Comparator group
Treatment:
Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab

Trial contacts and locations

1

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Central trial contact

Sina Asaadi, M.D; Maryam B Tabrizi, M.D

Data sourced from clinicaltrials.gov

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