Revisiting the Role of Aspirin for the Primary Prevention of Cardiovascular Disease.
Guillaume Marquis-Gravel, Matthew T Roe, Robert A Harrington...
https://pubmed.ncbi.nlm.nih.gov/31545683Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05702463
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With Type 2 Diabetes
Led by Montreal Heart Institute · Updated on 2025-12-03
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Montreal Heart Institute
Lead Sponsor
H
Heart and Stroke Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different dosing regimens of enteric-coated aspirin in patients with type 2 diabetes mellitus to understand their effects on platelet aggregation. The study aims to assess how well patients respond to aspirin and to find the regimen with the lowest number of non-responders. This phase 2, randomized, open-label pilot trial also seeks to determine the feasibility of conducting a larger, confirmatory trial in the future. Participants will first take 80 mg of enteric-coated aspirin once daily for seven days. Those who show incomplete platelet inhibition after this run-in phase will be randomly assigned to receive one of three aspirin regimens in a crossover design: 162 mg once daily, 81 mg twice daily, or 40 mg chewable twice daily. Each treatment period lasts seven days, separated by at least seven days of washout. During the study, blood samples will be collected to assess platelet function and serum salicylate levels. Throughout the trial, participants will attend multiple visits for blood draws and platelet function testing using Light Transmission Aggregometry. Adherence will be tracked by pill counts and questioning at visits. The primary outcomes include measuring the rate of aspirin non-responders and evaluating the feasibility of a larger trial by tracking screening, enrollment, retention, and consent rates. Secondary outcomes assess adherence, time to complete study procedures, and platelet response to different aspirin doses and other platelet activators. Total participation may extend over several months due to treatment and washout periods.
CONDITIONS
Brief Title
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- No chronic aspirin use in the previous 3 months and no aspirin use in the last 2 weeks
- Diagnosis of type 2 diabetes based on treatment or blood glucose criteria
- Willing to attend all study visits for both run-in and randomized phases
You will not qualify if you...
- Clinical atherosclerotic disease or definitive indication for aspirin
- Known allergy to aspirin
- Patients requiring dialysis
- Severe liver problems with ALT more than 3 times normal
- High risk of gastrointestinal bleeding or history of GI ulcers or bleeding
- Bleeding disorders
- Abnormal platelet count or hemoglobin
- Planned major surgery or dental procedure during study
- Chronic inflammatory diseases requiring regular anti-inflammatory drugs
- Current use of anticoagulants, antiplatelets, NSAIDs, or systemic steroids
- Active cancer or history of blood cancers
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 7 days
Participants take enteric coated aspirin 80 mg once daily for 7 days to assess baseline platelet function and aspirin response.
2 visits (in-person): one at day 0 and one at day 7
Treatment
Duration - 3 periods of 7 days each with washout periods of at least 7 days in between; longer washout up to 14 days allowed
Participants with incomplete platelet inhibition after run-in are randomized to receive one of three aspirin regimens for 7 days each, with at least 7 days washout between regimens. The regimens include EC ASA 162 mg once daily, EC ASA 81 mg twice daily, and chewable ASA 40 mg twice daily.
Multiple visits: at the start and end of each 7-day regimen, including supervised dosing and blood sample collection
Trial Site Locations
Total: 1 location
1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
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Research Team
G
Guillaume Marquis Gravel, MD, MSc
M
Marie Lordkipanidzé B. Pharm, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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Published Research Related To This Trial
Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus.
ASCEND Study Collaborative Group, Louise Bowman, Marion Mafham...
https://pubmed.ncbi.nlm.nih.gov/30146931Heterogeneity in platelet cyclooxygenase inhibition by aspirin in coronary artery disease.
Marie Lordkipanidzé, Chantal Pharand, Erick Schampaert...
https://pubmed.ncbi.nlm.nih.gov/20207433Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus.
Deepak L Bhatt, Tilo Grosser, Jing-Fei Dong...
https://pubmed.ncbi.nlm.nih.gov/28089180