Comparing two doses of Aspirin for preventing strokes in patients with blunt cerebrovascular injury
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).
This study tests whether a lower dose of Aspirin can prevent strokes just as well as a higher dose in adults with blunt cerebrovascular injury.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05868525 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different doses of Aspirin (81 mg and 325 mg) in preventing strokes in patients diagnosed with blunt cerebrovascular injury. The study will assess whether the lower dose of Aspirin is as effective as the higher dose in preventing strokes and whether it results in fewer hemorrhagic complications. Patients will be monitored for stroke occurrence and any adverse effects related to the medication. The trial is designed for adults aged 18 and older who have been diagnosed with this specific type of injury.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with blunt cerebrovascular injury confirmed by computed tomography angiography.
Not a fit: Patients under 18, pregnant women, or those with contraindications to Aspirin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer and equally effective dosing of Aspirin for stroke prevention in patients with blunt cerebrovascular injuries.
How similar studies have performed: While there have been studies on Aspirin for various conditions, this specific comparison of doses in blunt cerebrovascular injury is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Loma Linda, California
- Loma Linda University Medical Center — Loma Linda, California, United States (Recruiting)
Study contacts
- Study coordinator: Maryam B Tabrizi, M.D
- Email: MTabrizi@llu.edu
- Phone: (909) 558-4286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.