Evaluating oral peri-operative acetylsalicylic acid in subjects undergoing endovascular coiling-only of unruptured brain aneurysms

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Calgary

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 Apr 2026 → ongoing

Decision date (initial)

2024-10-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University of Calgary Foothills Medical Centre

External identifiers

EU CT number

2024-517674-23-00

EudraCT number

2022-003315-28

ClinicalTrials.gov

NCT04192955

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate lower incidence of stroke in acetylsalicylic acid (ASA) vs placebo arms after coiling.

Secondary objectives 5

1. To determine if ASA is associated with lower risks of embolic or cognitive sequalae.
2. To test whether ASA use is associated with comparable safety to placebo in terms of all-cause mortality and bleeding risks.
3. To assess whether treatment with ASA is associated with better short- and long-term cognitive and neuropsychiatric outcomes up to 1-year post-procedure
4. To examine these outcomes in patients with different burdens of iatrogenic brain infarcts, and assess how any treatment effects of ASA are mediated by this infarct burden
5. To assess whether ASA is associated with better cognitive-related activities of daily living (ADLs) and health-related quality of life up to 1-year post-procedure

Conditions and MedDRA coding

Subjects undergoing elective endovascular coiling-only repair of unruptured brain aneurysms.

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 18 years
2. Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment
3. Functionally independent at baseline (modified Rankin scale <3)
4. Informed consent and availability of the subject for the entire study period

Exclusion criteria 12

1. 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
2. Planned treatment for dissecting or mycotic brain aneurysm
3. Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization
4. Allergy, hypersensitivity, or contraindication to ASA or their risk markers as: a) A history of asthma caused by salicylates or substances with similar effect. b) Severe hepatic or renal impairment. c) Severe cardiac insufficiency. d) Patients already receiving therapeutic heparin treatment. e) Patients with cross-hypersensitivity to other NSAIDs (indomethacin, phenylbutazone, ibuprofen, diflunisal). e) Methotrexate in doses higher than 15 mg/week.
5. Unable to take the study drug orally for any reason
6. Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants
7. Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals)
8. 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.
9. Pregnancy or breastfeeding
10. Planned treatment of more than one aneurysm in the same procedure.
11. 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.
12. Subjects who are under legal protection measure (curatelle/tutelle)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of embolic strokes (clinically or on DWI-MRI) in ASA vs placebo on Day 5 of the study (12-48 hours following coiling procedure).

Secondary endpoints 11

1. Clinical thromboembolic events by Day 90 following coiling
2. Count of new DWI lesions on post-coiling MRI
3. Frequency of large (> 10 cc volume) strokes on DWI MR
4. Incidence of cognitive decline from baseline to 90-day follow-up
5. Incidence of visible thrombus formation during the coiling procedure
6. Total volume of embolic strokes on DWI MR imaging
7. Death rate within 90 days following coiling in the ASA vs. placebo group
8. Any peri-operative hemorrhagic complication (intracranial hemorrhage, retroperitoneal hematoma, upper or lower gastrointestinal bleeding, or any bleeding stratified as major according to TIMI (Thrombolysis in Myocardial Infarction))
9. To assess whether treatment with ASA is associated with better short- and long-term cognitive and neuropsychiatric outcomes up to 1-year post-procedure
10. To examine these outcomes in patients with different burdens of iatrogenic brain infarcts, and assess how any treatment effects of ASA are mediated by this infarct burden
11. To assess whether ASA is associated with better cognitive-related activities of daily living (ADLs) and health-related quality of life up to 1-year post-procedure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Calgary

Sponsor organisation

University Of Calgary

Address

2500 University Drive Northwest

City

Calgary

Postcode

T2N 1N4

Country

Canada

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Coordinating Investigator France

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Coordinating Investigator France

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications