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Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms

NCT04192955 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2023-05-06

No results posted yet for this study

Summary

This trial is a is a prospective, randomized (1:1) placebo-controlled, clinical trial with blinded endpoint assessment of 440 participants with unruptured brain aneurysm planned for endovascular treatment using coiling-only approach (primary coiling or using balloon-assistance but not stenting) to test if oral acetylsalicylic acid (325 mg/ day for a total of 5 days) is superior placebo in preventing clinical and silent strokes. The primary outcome is a clinical or silent stroke at the time of discharge assessed by clinical examination and MRI brain. Participants will return to the clinic or be contacted by phone for the end of study procedures on Day 90 to collect functional outcome data.

Conditions

  • Unruptured Cerebral Aneurysm

Interventions

DRUG

Acetyl Salicylate

Tablets

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Mohammed A Almekhlafi, MD MSc FRCPC · University of Calgary

  • Mayank Goyal, MD PhD FRCPC · University of Calgary

  • Linda Andersen, PhD · University of Calgary

  • Craig Doram, PEng · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192955 on ClinicalTrials.gov