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

NCT05702463 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-03

No results posted yet for this study

Summary

This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.

Conditions

  • Platelet Aggregation
  • Type 2 Diabetes
  • Aspirin
  • Diabetes Mellitus, Type 2
  • Platelet Aggregation Inhibitors

Interventions

DRUG

Aspirin 81Mg Ec Tab twice daily for 7 days

Participants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.

DRUG

Aspirin 40Mg Chew Tab twice daily for 7 days

Participants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.

DRUG

Aspirin 162 mg EC Tab once daily for 7 days

Participants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Guillaume Marquis Gravel, MD, MSc · ICM Co. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2027-06-01
Completion
2027-07-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05702463 on ClinicalTrials.gov