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Nonsteroidal Anti-inflammatory Drug

Low-Dose Aspirin for Type 2 Diabetes (APPEASED Trial)

Phase < 1
Recruiting
Led By Guillaume Marquis-Gravel, MD, MSc
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Type 2 diabetes, based on at least one of the following criteria: (1) Chronic treatment with oral antihyperglycemic agents or insulin therapy, (2) Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h), (3) 2-h Plasma Glucose (2h-PG) ≥200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT), (4) A1C ≥ 6.5% (48 mmol/mol)
Must not have
History of hematological malignancy or myelodysplasia
Chronic inflammatory disease requiring regular anti-inflammatory treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days.
Awards & highlights

Summary

This trial tests if a daily dose of 80mg enteric-coated aspirin can help type 2 diabetic patients. It will measure platelet function at the start and end of the trial.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include gastrointestinal issues like stomach ulcers or bleeding, especially if there's a history of H. pylori infection or previous GI tract problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have type 2 diabetes based on my treatment or test results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had blood cancer or a condition that affects how my blood cells form.
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I am on regular medication for a chronic inflammatory condition.
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I am on long-term medication for blood thinning, pain, inflammation, or steroids.
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I have a bleeding disorder.
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I have a condition that requires me to take aspirin due to heart or artery disease.
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My cancer is currently active.
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I have a high risk of bleeding in my stomach or intestines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incomplete platelet aggregation inhibition by aspirin at 7 days.
Secondary study objectives
Platelet aggregation response to various agonists
Serum levels of thromboxane B2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aspirin therapyExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
122 Previous Clinical Trials
78,710 Total Patients Enrolled
Institut de Recherches Cliniques de MontrealOTHER
70 Previous Clinical Trials
10,318 Total Patients Enrolled
Guillaume Marquis-Gravel, MD, MScPrincipal InvestigatorMontreal Heart Institute
3 Previous Clinical Trials
1,258 Total Patients Enrolled
~12 spots leftby Sep 2025
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