| Trial ID: | L4611 |
| Source ID: | NCT05105919
|
| Associated Drug: |
Aspirin 80 Mg Ec Tab
|
| Title: |
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes
|
| Acronym: |
APPEASED
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Aspirin 80 mg EC Tab
|
| Outcome Measures: |
Primary: Incomplete platelet aggregation inhibition by aspirin at 7 days., Incomplete platelet aggregation inhibition will be defined as ≥ 20% of residual platelet aggregation in response to arachidonic acid at a concentration of 1mM, measured by LTA (Light Transmission Aggregometry)., 7 days. | Secondary: Serum levels of thromboxane B2, Serum levels of thromboxane B2, measured by immunoassay \> 3.1 ng/ml will be considered as evidence of recovery of platelet function., 7 days.|Platelet aggregation response to various agonists, Platelet reactivity to various agonists such as ADP (Adenosine Diphosphate), TRAP (Thrombin receptor activating peptide), epinephrine and collagen will be assessed by LTA (Light Transmission Agregometry)., 7 days.
|
| Sponsor/Collaborators: |
Sponsor: Montreal Heart Institute | Collaborators: Institut de Recherches Cliniques de Montreal
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2021-08-26
|
| Completion Date: |
2024-07-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-03-15
|
| Locations: |
Montreal Heart Institute, Montréal, Quebec, H1T 1C8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT05105919
|
