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Aspirin for Giant Cell Arteritis

(ASPIRE-GCA Trial)

JM
Overseen ByJean-Paul Makhzoum, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JM

Jean-Paul Makhzoum, MD

Principal Investigator

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Giant Cell Arteritis (GCA), a condition that causes inflammation of blood vessels. Participants should not have conditions or risks that make taking aspirin unsafe, such as certain bleeding disorders or allergies to aspirin.

Inclusion Criteria

I was diagnosed with GCA within the last 30 days.
I have giant cell arteritis confirmed by biopsy or imaging.
I have started standard treatment for giant cell arteritis.
See 1 more

Exclusion Criteria

I need to take antiplatelet medication due to heart or blood vessel problems.
Presence of a condition expected to limit survival to less than 1 year as per investigator's opinion
I have lost vision in both eyes permanently.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Acetyl Salicylic Acid (ASA)

Trial Overview

The study is testing whether taking low-dose aspirin daily can help prevent serious complications like heart attack and stroke in people with GCA. Participants are randomly assigned to receive either aspirin or a placebo (inactive pill).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Acetyl Salicylic Acid (ASA)Experimental Treatment1 Intervention
Group II: Control ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials
17
Recruited
4,600+

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