Giant Cell Arteritis (GCA)Phase 3ASPIRE-GCANCT07908082
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
A Phase 3 study testing Acetyl Salicylic Acid (ASA) in people with Giant Cell Arteritis (GCA) and Acute Coronary Syndrome (ACS), run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS), Ishemic and Thrombotic Complications
- What is being tested?
- Acetyl Salicylic Acid (ASA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2027to Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with newly diagnosed GCA (≤30 days since diagnosis);
- GCA fulfilling the 2022 ACR-EULAR Classification Criteria for GCA, supported by positive temporal artery histology, or compatible cranial or large-vessel imaging;
- Initiation of standard-of-care treatment for GCA, with or without intravenous glucocorticoids;
- Ability to provide informed consent and participate in virtual study procedures.
Who cannot join
- 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);
- All-cause bilateral permanent vision loss during the screening period;
- Chronic use of therapeutic anticoagulation at baseline;
- Presence of a condition that, in the investigator's opinion, is expected to limit survival to less than 1 year;
- Any contraindication to low-dose ASA according to the product monograph.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Vasculitis Clinic, Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J1C5
Jean-Paul Makhzoum, MD, MSc, 514-338-2222 ext. 2725, jean-paul.makhzoum@umontreal.ca
Rachel Cloutier, MSc, rachel.cloutier.cnmtl@ssss.gouv.qc.ca
About this study
Official title: Aspirin for the Prevention of Ischemic-Related Events in Giant Cell Arteritis Pilot (ASPIRE-GCA Pilot)
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.
Read the detailed description
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.
- Conditions
- Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS), Ishemic and Thrombotic Complications
- Being tested
- Acetyl Salicylic Acid (ASA), Placebo
- Medical subject headings
- Giant Cell Arteritis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Salicylic Acid (ASA)Drug
Participants will receive blinded low-dose ASA (80 mg orally once daily) for 52 weeks.
PlaceboDrug
Participants will receive blinded low-dose ASA placebo (orally once daily) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acetyl Salicylic Acid (ASA) | Experimental | Participants will receive low-dose ASA (80 mg orally once daily) for 52 weeks, in addition to standard-of-care therapy for GCA. Receives: Drug: Acetyl Salicylic Acid (ASA) |
| Control Arm | Placebo comparator | Participants will receive a matching low-dose ASA placebo (orally once daily) for 52 weeks, in addition to standard-of-care therapy for GCA. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 18 months
Secondary outcomes (9)
Study treatment initiation, assessed as the proportion of randomized participants who initiate study treatment.
Measured: 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.
Measured: 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.
Measured: Up to 12 months following randomization
Participant retention, defined as the proportion of randomized participants completing the 12-month follow-up visit.
Measured: 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.
Measured: 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.
Measured: Up to 12 months following randomization
Barriers for recruitment, assessed by the frequency of reasons for ineligibility.
Measured: Through study completion, an average of 18 months
Barriers for adherence, assessed by the frequency of reasons for treatment discontinuation.
Measured: Through study completion, an average of 18 months
Barriers for retention, assessed by the frequency of reasons for withdrawal from the trial.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startOct 2027 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Makhzoum, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Jean-Paul Makhzoum, MD, Study chair, Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908082
- Sponsor's protocol ID
- 2027-3273
- Acronym
- ASPIRE-GCA
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for the Prevention of Ischemic-Related Events in Giant Cell Arteritis Pilot (ASPIRE-GCA Pilot)
- ClinicalTrials.gov ID
- NCT07908082
- Acronym / sponsor ID
- ASPIRE-GCA / 2027-3273
- Conditions
- Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS), Ishemic and Thrombotic Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- Oct 2027 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl Salicylic Acid (ASA) | Experimental | Drug: Acetyl Salicylic Acid (ASA)Participants will receive low-dose ASA (80 mg orally once daily) for 52 weeks, in addition to standard-of-care therapy for GCA. |
| Control Arm | Placebo comparator | Drug: PlaceboParticipants will receive a matching low-dose ASA placebo (orally once daily) for 52 weeks, in addition to standard-of-care therapy for GCA. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with newly diagnosed GCA (≤30 days since diagnosis);
- GCA fulfilling the 2022 ACR-EULAR Classification Criteria for GCA, supported by positive temporal artery histology, or compatible cranial or large-vessel imaging;
- Initiation of standard-of-care treatment for GCA, with or without intravenous glucocorticoids;
- Ability to provide informed consent and participate in virtual study procedures.
Key exclusion criteria (5 listed)
- 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);
- All-cause bilateral permanent vision loss during the screening period;
- Chronic use of therapeutic anticoagulation at baseline;
- Presence of a condition that, in the investigator's opinion, is expected to limit survival to less than 1 year;
- Any contraindication to low-dose ASA according to the product monograph.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl Salicylic Acid (ASA)Participants will receive blinded low-dose ASA (80 mg orally once daily) for 52 weeks. | Drug | Acetyl Salicylic Acid (ASA) |
| PlaceboParticipants will receive blinded low-dose ASA placebo (orally once daily) for 52 weeks. | Drug | Control Arm |
Primary outcome
Recruitment rate defined as the number of participants randomized per center-month.
Time frame: Through study completion, an average of 18 months
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.
9 secondary outcomes
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Global survey of GCA experts: International practice patterns and beliefs concerning intravenous methylprednisolone and low-dose aspirin in giant cell arteritisLink provided by the sponsor.
- Scoping review: Risk factors for acute coronary syndrome in patients with giant cell arteritisLink provided by the sponsor.
- Scoping review: Markers of Giant Cell Arteritis in Patients Presenting With Ischemic StrokeLink provided by the sponsor.
- Vasculitis Clinic - University of MontrealLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Paul Makhzoum, MD study chair
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetyl Salicylic Acid (ASA) in people with Giant Cell Arteritis (GCA) and Acute Coronary Syndrome (ACS), run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul Makhzoum, MD (514-338-2222 ext. 2725, jean-paul.makhzoum@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate defined as the number of participants randomized per center-month. (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.