A Phase 3 interventional study of Acetyl Salicylic Acid (ASA) and Placebo in Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS) and Ishemic and Thrombotic Complications, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Not yet recruiting at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Phase 3, Interventional, and Prevention
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.
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.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's planned enrollment of 120 is above the median of 64 across 65 interventional studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 34 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive low-dose ASA (80 mg orally once daily) for 52 weeks, in addition to standard-of-care therapy for GCA.
Drug: Acetyl Salicylic Acid (ASA)
Participants will receive a matching low-dose ASA placebo (orally once daily) for 52 weeks, in addition to standard-of-care therapy for GCA.
Drug: Placebo
Participants will receive blinded low-dose ASA (80 mg orally once daily) for 52 weeks.
Participants will receive blinded low-dose ASA placebo (orally once daily) for 52 weeks.
Recruitment rate defined as the number of participants randomized per center-month.
Number of participants randomized per center-month, counting each center from the date it is activated and able to enroll participants until completion of recruitment.
Time frame: Through study completion, an average of 18 months
Study treatment initiation, assessed as the proportion of randomized participants who initiate study treatment.
Time frame: Up to month 3 following randomization
Time to study treatment initiation, assessed as the number of days from randomization to first study treatment administration among randomized participants who initiate treatment.
Time frame: Up to 30 days following randomization
Treatment adherence, assessed using the proportion of days covered.
The proportion of days covered is calculated as the number of days covered by the dispensed study medication divided by the total number of days in the treatment period, multiplied by 100.
Time frame: Up to 12 months following randomization
Participant retention, defined as the proportion of randomized participants completing the 12-month follow-up visit.
Time frame: Up to 12 months following randomization
Completeness of follow-up data, assessed as the proportion of randomized participants completing the 12-month visit for whom all clinical outcome data required for the definitive trial are available.
Time frame: Up to 12 months following randomization
Study-drug delivery performance, assessed as the proportion of participants experiencing ≥1 delivery-related delay resulting in delayed treatment initiation or treatment interruption.
Time frame: Up to 12 months following randomization
Barriers for recruitment, assessed by the frequency of reasons for ineligibility.
Time frame: Through study completion, an average of 18 months
Barriers for adherence, assessed by the frequency of reasons for treatment discontinuation.
Time frame: Through study completion, an average of 18 months
Barriers for retention, assessed by the frequency of reasons for withdrawal from the trial.
Time frame: Through study completion, an average of 18 months
Time to first ischemic event (in days)
The efficacy composite outcome of the full trial will be the time to first ischemic event, defined as the first occurence of ischemic death, new ischemic vision loss, ischemic stroke, transient ischemic attack, myocardial infarction, unstable angina requiring hospitalization, or acute limb ischemia requiring intervention.
Time frame: Up to 12 months following randomization
Time to first major bleeding event (in days)
Major bleeding is defined according to the Bleeding Academic Research Consortium criteria.
Time frame: Up to 12 months following randomization
Plan to share: No
Start is estimated for Oct 2027; primary completion for Oct 2030, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Aspirin
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal