Could a different aspirin regimen better protect diabetic hearts?

NCT ID NCT05702463

Disease control Sponsor: Montreal Heart Institute Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether changing the dose or form of aspirin can improve blood clotting control in people with type 2 diabetes who don't respond well to standard enteric-coated aspirin. About 30 participants will try three different aspirin regimens over several weeks. The main goal is to see if a larger study is possible and which regimen works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Aspirin (enteric-coated and chewable tablets)
What this could lead to: If successful, this could identify a better aspirin regimen for people with type 2 diabetes to reduce their risk of heart attack or stroke.
What could go wrong: This is a small, early-phase feasibility study, not a large trial. The results may not apply to everyone, and the best regimen might still not work for many participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years; 2. Participant must be naïve to ASA, defined as absence of chronic treatment with ASA within the previous 3 months, and of any ASA use within the previous 2 weeks; 3. Type 2 diabetes, based on at least one of the following criteria: (5) * Chronic treatment with oral antihyperglycemic agents or insulin therapy; * Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h); * 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT); * A1C ≥ 6.5% (48 mmol/ml); 4. Willing to attend all study visits of both the run-in and randomized phases of the trial. Exclusion Criteria: 1. Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current; 2. Known hypersensitivity to ASA; 3. Patient requiring dialysis; 4. Severe hepatic insufficiency or ALT \> 3 x ULN; 5. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract; 6. Bleeding diathesis; 7. Platelet count or hemoglobin levels outside of the normal reference range; 8. Planned major surgical procedure or dental procedure during the course of the study; 9. Chronic inflammatory disease requiring regular anti-inflammatory treatment; 10. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids; 11. Active cancer; 12. History of hematological malignancy or myelodysplasia; 13. Pregnant or lactating women;

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aspirin Diabetes mellitus type 2 Platelet aggregation Platelet aggregation inhibitors Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a different aspirin regimen better protect diabetic hearts?

What the study statuses mean