Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II

Launched by MONTREAL HEART INSTITUTE · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different doses of enteric-coated aspirin affect patients with type 2 diabetes. The goal is to find out how well aspirin works to prevent blood platelets from sticking together, which is important for heart health. The trial will start with participants taking 80 mg of aspirin daily for a week. If their blood tests show that the aspirin isn’t fully working, they will be assigned to one of three different groups where they will try higher doses or a chewable form of aspirin. This research aims to see if a larger study should be done in the future and to identify which dose works best.

To be eligible for this study, participants must be at least 18 years old and have type 2 diabetes. They should not have taken aspirin regularly in the last three months. This trial is open to both men and women, and participants need to be willing to attend all study visits. Throughout the study, participants can expect to have their blood tested to check how well the aspirin is working. It’s important to know that people with certain medical conditions or those who are pregnant or breastfeeding cannot participate in this trial.

Gender

ALL

Eligibility criteria

• 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;