Low-Dose Aspirin for Type 2 Diabetes

(APPEASED Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Guillaume Marquis-Gravel, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Montreal Heart Institute

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase 1 study will include patients suffering from type 2 diabetes mellitus and will study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. The aims are to determine the feasibility of a phase 2 larger scale trial, and to characterize the prevalence of incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily. Platelet function will be assessed at baseline and a day 7.

Eligibility Criteria

This trial is for adults over 18 with stable type 2 diabetes who haven't taken aspirin in the last 3 months. They should not have a history of bleeding disorders, active cancer, abnormal blood counts, or be pregnant. They must also avoid certain medications like anticoagulants and anti-inflammatories.

Inclusion Criteria

I am 18 years old or older.

I have type 2 diabetes based on my treatment or test results.

Willing to attend all study visits

Exclusion Criteria

I have had blood cancer or a condition that affects how my blood cells form.

I am on regular medication for a chronic inflammatory condition.

Your platelet count or hemoglobin levels are not within the normal range.

Participant Groups

The study tests how patients with type 2 diabetes respond to a daily dose of enteric-coated aspirin (80 mg) over one week. It aims to prepare for a larger phase 2 trial and check how well this low-dose aspirin prevents blood clots.

Group I: Aspirin therapy Experimental Treatment 1 Intervention

All participants will be assigned to aspirin therapy. Participants will receive 80 mg of enteric coated aspirin per day for a 7 day period.

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

🇪🇺 Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

🇺🇸 Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

🇨🇦 Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

🇨🇳 Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Montreal Heart Institute Montréal, Canada

Who Is Running the Clinical Trial?

Montreal Heart Institute Lead Sponsor

Institut de Recherches Cliniques de Montreal Collaborator

References