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Nonsteroidal Anti-inflammatory Drug

Aspirin for Unruptured Brain Aneurysm (EVOLVE Trial)

Phase 3

Recruiting

Led By Mohammed A Almekhlafi, MD MSc FRCPC

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Functionally independent at baseline (modified Rankin scale <3).

Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90 following coiling.

Awards & highlights

EVOLVE Trial Summary

This trial is testing if aspirin is better than placebo at preventing strokes in people with unruptured brain aneurysms.

Who is the study for?

This trial is for adults with unruptured brain aneurysms suitable for coiling-only treatment. They must be functionally independent and able to give consent. Excluded are those needing complex treatments, unable to take oral medication or undergo MRI, have certain medical risks like bleeding disorders, pregnant or breastfeeding women, and anyone on antiplatelet or anticoagulant therapy.Check my eligibility

What is being tested?

The study tests if taking acetylsalicylic acid (325 mg/day for 5 days) is better than a placebo in preventing strokes after endovascular coiling of unruptured brain aneurysms. The main goal is to see if there's a stroke at discharge time by clinical exam and MRI, with follow-up functional outcome data collected on Day 90.See study design

What are the potential side effects?

Possible side effects of acetylsalicylic acid include increased risk of bleeding, digestive issues like stomach pain or heartburn, allergic reactions, and potentially liver or kidney problems in susceptible individuals.

EVOLVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can do most daily activities by myself.

Select...

I have a brain aneurysm that can be treated with coiling.

EVOLVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical or silent stroke

Secondary outcome measures

Count of new DWI lesions on post-coiling MRI

Death rate

Frequency of large (> 10 cc volume) strokes on DWI MRI

+5 more

EVOLVE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

Acetylsalicylic acid (ASA) will be given orally at a dose of 324 mg to be taken daily starting 3 days prior to the planned coiling procedure day, on the procedure day, and for one-day post-procedure.

Group II: ControlPlacebo Group1 Intervention

Lactose100-mg tablets to be taken daily starting 3 days prior to the planned coiling procedure day, on the procedure day, and for one-day post-procedure.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

868,714 Total Patients Enrolled

Linda Andersen, PhDStudy DirectorUniversity of Calgary

Craig Doram, PEngStudy DirectorUniversity of Calgary

Media Library

Acetyl Salicylate (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04192955 — Phase 3

Cerebral Aneurysm Research Study Groups: Active, Control

Cerebral Aneurysm Clinical Trial 2023: Acetyl Salicylate Highlights & Side Effects. Trial Name: NCT04192955 — Phase 3

Acetyl Salicylate (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04192955 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we still have the opportunity to sign up for this experiment?

"If you refer to clinicaltrials.gov, you'll see that this trial is still enrolling patients. The listing was created on 7/14/2020, and the most recent update was on 10/5/2021."

Answered by AI

Has the FDA cleared Active for use?

"Active has undergone Phase 3 clinical trials, so there is some evidence of its efficacy as well as multiple rounds of data supporting its safety. Therefore, our team rates it as a 3 on our safety scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04192955.