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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days.
Awards & highlights

APPEASED Trial 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.Check my eligibility
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.See study design
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.

APPEASED Trial 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.

APPEASED Trial 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

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

APPEASED 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
120 Previous Clinical Trials
68,769 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
2 Previous Clinical Trials
1,158 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes
Guillaume Marquis-Gravel 2021. "Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05105919.
All > Diabetes Type 2 > Durlaza
~14 spots leftby Apr 2025
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