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

NCT04192955 | Unknown Phase 3 DMC

• 1 other identifier: Version 2.0
• Study Type: interventional
• Target: 440
• Locations: 2 countries
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinical or silent stroke

  Incidence of embolic strokes (clinically or on DWI-MRI)

  within 2-4 days of completion of the coiling procedure

Secondary Outcomes (8)

• Symptomatic stroke

  Day 90 following coiling.

• Death rate

  within 90 days following coiling

• Peri-operative hemorrhagic complication

  within 90 days following coiling

• Count of new DWI lesions on post-coiling MRI

  within 2-4 days of completion of the coiling procedure

• Total volume of new DWI lesions on post-coiling MRI

  within 2-4 days of completion of the coiling procedure

Study Arms (2)

Active

ACTIVE COMPARATOR

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.

Drug: Acetyl Salicylate

Control

PLACEBO COMPARATOR

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.

Drug: Acetyl Salicylate

Interventions

Acetyl Salicylate DRUG

Tablets

Active; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Planned complex aneurysm treatment including use of any device that requires post-operative antiplatelet therapy (stent-assisted coiling or flow-diverter device), or endovascular vessel sacrifice.
• Dissecting or mycotic brain aneurysm.
• Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization.
• Allergy or contraindication to ASA.
• Unable to take study drug orally for any reason.
• Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants.
• Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals).
• Any other medical condition that the site investigator deems would put the subject at excessive risk by participation in the study (e.g. active bleeding, symptomatic peptic ulcer disease, liver or kidney failure, thrombocytopenia or coagulopathy) or an expected life expectancy less than one year, or that would result in an inability to collect radiological outcomes and clinical outcomes at 90 days.
• Pregnancy or breastfeeding.
• Prior enrollment in EVOLVE trial for another aneurysm.
• Participation in another clinical trial of an investigational drug, device or procedure if the subject received the trial drug, device or procedure in the preceding 30 days from the anticipated coiling date.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (9)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

U of Alberta

Edmonton, Alberta, Canada

RECRUITING

Dalhousie University

Halifax, Nova Scotia, Canada

RECRUITING

McMaster University

Hamilton, Ontario, Canada

RECRUITING

Toronto St Michael's Hospital

Toronto, Ontario, Toronto, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

RECRUITING

McGill University

Montreal, Quebec, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

RECRUITING

Centre Hospitalier Régional Universitaire de Tours

Tours, Centre-Val de Loire, France

RECRUITING

Study Officials

• Mohammed A Almekhlafi, MD MSc FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Mayank Goyal, MD PhD FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Linda Andersen, PhD

  University of Calgary

  STUDY DIRECTOR

• Craig Doram, PEng

  University of Calgary

  STUDY DIRECTOR

Central Study Contacts

Mohammed A Almekhlafi, MD MSc FRCPC

CONTACT

403-944-3458; mohammed.almekhlafi1@ucalgary.ca

Karla Ryckborst, RN BN CCRP

CONTACT

karla.ryckborst@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 10, 2019
• Study Start: July 14, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); FR (1)