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Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms(EVOLVE): A Phase 3 Multicenter Randomized Study

Who is this study for? Adult patients with Intracranial Aneurysm
What treatments are being studied? Acetylsalicylate Acid
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

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

• Informed consent and availability of the subject for the entire study period.

Locations
Other Locations
Canada
Foothills Medical Center
RECRUITING
Calgary
U of Alberta
RECRUITING
Edmonton
Dalhousie University
RECRUITING
Halifax
McMaster University
RECRUITING
Hamilton
McGill University
RECRUITING
Montreal
University of Saskatchewan
RECRUITING
Saskatoon
Toronto St Michael's Hospital
RECRUITING
Toronto
Toronto Western Hospital
RECRUITING
Toronto
France
Centre Hospitalier Régional Universitaire de Tours
RECRUITING
Tours
Contact Information
Primary
Mohammed A Almekhlafi, MD MSc FRCPC
mohammed.almekhlafi1@ucalgary.ca
403-944-3458
Backup
Karla Ryckborst, RN BN CCRP
karla.ryckborst@albertahealthservices.ca
Time Frame
Start Date: 2020-07-14
Estimated Completion Date: 2027-07
Participants
Target number of participants: 440
Treatments
Active_comparator: Active
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.
Placebo_comparator: Control
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.
Authors
Mayank Goyal, Mohammed A Almekhlafi
Related Therapeutic Areas
Sponsors
Leads: University of Calgary

This content was sourced from clinicaltrials.gov