Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · NCT07908082 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2030-10.
The ASPIRE-GCA Pilot trial will assess the feasibility of a future randomized controlled trial (RCT) evaluating the efficacy of low-dose ASA in preventing ischemic complications in patients with Giant Cell Arteritis (GCA). ASPIRE-GCA Pilot builds on extensive preparatory work and the findings from this study will inform key feasibility outcomes, including recruitment rate, study-drug delivery and treatment initiation, medication adherence, participant retention, and completeness of follow-up data.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal Academic / other |
| Drugs / interventions | Acetyl Salicylic Acid (ASA), Placebo |
| Locations | 1 site (Canada) |
| Trial ID | NCT07908082 on ClinicalTrials.gov |
What this trial studies
ASPIRE-GCA Pilot is a national, multicenter, randomized, double-blind, placebo-controlled, decentralized trial conducted in centers of the Canadian Vasculitis Research Network (CanVasc), designed to evaluate the feasibility of conducting the full international RCT. To examine this objective, 120 eligible patients with newly diagnosed GCA will be randomized at a 1:1 ratio to receive low-dose ASA (80 mg/day) or placebo for 52 weeks, in addition to standard-of-care therapy for GCA. Participants will then be followed for 13 months.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults with newly diagnosed GCA (≤30 days since diagnosis); 2. GCA fulfilling the 2022 ACR-EULAR Classification Criteria for GCA, supported by positive temporal artery histology, or compatible cranial or large-vessel imaging; 3. Initiation of standard-of-care treatment for GCA, with or without intravenous glucocorticoids; 4. Ability to provide informed consent and participate in virtual study procedures. Exclusion Criteria: 1. Established indication for antiplatelet therapy (e.g., prior or current myocardial infarction, ischemic stroke, transient ischemic attack, or known coronary, cerebrovascular, or peripheral arterial disease); 2. All-cause bilateral permanent vision loss during the screening period; 3. Chronic use of therapeutic anticoagulation at baseline; 4. Presence of a condition that, in the investigator's opinion, is expected to limit survival to less than 1 year; 5. Any contraindication to low-dose ASA according to the product monograph.
Where it's running
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Vasculitis Clinic, Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Study contacts
- Principal investigator: Jean-Paul Makhzoum, MD — Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
- Study coordinator: Jean-Paul Makhzoum, MD
- Email: jean-paul.makhzoum@umontreal.ca
- Phone: 514-338-2222
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.