Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04192955 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: EVOLVE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 2024 to Mar 2027
    • Study completion date: Dec 2024 to Jul 2027
    v7
  2. Site details revised at 1 of 9 sitesv6
  3. Study sites: 1 to 9v5
  4. Primary completion date: Jul 2023 to Sep 2024
    • Study completion date: Oct 2023 to Dec 2024
    v4
  5. Secondary endpoints revised (8)v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jan 2020 to Jul 14, 2020
    • Study sites: 0 to 1
    • Primary completion date: Jan 2023 to Jul 2023
    • Study completion date: Apr 2023 to Oct 2023
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04192955
Lead Sponsor University of Calgary
Conditions
(from sponsor)		 Unruptured Cerebral Aneurysm
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov