- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05702463
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II (APPEASEDII)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Guillaume Marquis Gravel, MD, MSc
- Phone Number: ext 3635 514-376-3330
- Email: guillaume.marquis.gravel@umontreal.ca
Study Contact Backup
- Name: Marie Lordkipanidzé B. Pharm, Ph.D.
- Phone Number: 2694 514-376-3330
- Email: marie.lordkipanidze@umontreal.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T 1C8
- Recruiting
- Montreal Heart Institute
-
Contact:
- Guillaume Marquis-Gravel, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years;
- 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;
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);
- Willing to attend all study visits of both the run-in and randomized phases of the trial.
Exclusion Criteria:
- Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
- Known hypersensitivity to ASA;
- Patient requiring dialysis;
- Severe hepatic insufficiency or ALT > 3 x ULN;
- High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
- Bleeding diathesis;
- Platelet count or hemoglobin levels outside of the normal reference range;
- Planned major surgical procedure or dental procedure during the course of the study;
- Chronic inflammatory disease requiring regular anti-inflammatory treatment;
- Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
- Active cancer;
- History of hematological malignancy or myelodysplasia;
- Pregnant or lactating women;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EC ASA 162 mg once daily for 7 days
|
Participants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.
Other Names:
|
Experimental: EC ASA 81 mg twice daily for 7 days
|
Participants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.
Other Names:
|
Experimental: chewable ASA 40 mg twice daily for 7 days
|
Participants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe the screening rate to evaluate the feasibility of a larger scale randomized controlled trial.
Time Frame: 1 year
|
Determine the average number of potential participants referred to us from the Montreal Clinical Research Institute (IRCM), Centre Épic, Montreal Heart Institute and the COLCOT-T2D study who are screened per month. Hypothesis : at least 40 potential participants per month will be screened on average |
1 year
|
Describe the enrollment rate by the proportion of referred participants who are eligible to evaluate the feasibility of a larger scale randomized controlled trial.
Time Frame: 1 year
|
Hypothesis : at least 70 percent of referred patients will be eligible
|
1 year
|
Describe the enrollment rate by the proportion of eligible participants who consent to evaluate the feasibility of a larger scale randomized controlled trial.
Time Frame: 1 year
|
Hypothesis : At least 40 percent of eligible patients will give their consent to participate in the run-in phase and the study
|
1 year
|
Describe the retention rate to evaluate the feasibility of a larger scale randomized controlled trial.
Time Frame: 1 year
|
Determine the retention rate of randomized participants Hypothesis : at least 85 percent of all randomized subjects will complete all study visits |
1 year
|
Among initial ASA non-responder participants, define the proportion of participants that remain ASA non-responders with different formulations and dosing regimens of ASA.
Time Frame: 1 year
|
Hypothesis : in at least one of the regimens studied, the proportion of ASA non-responders will be less than 50 percent.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence rate to study protocol
Time Frame: 1 year
|
Hypothesis : At least 90 percent of participants will be adherent to all study doses.
|
1 year
|
Average time per participant required to complete study enrolment and all data collection.
Time Frame: 1 year
|
Endpoints : Average time required to screen for, consent and enroll per participant and average time to complete study procedures and data collection per participant |
1 year
|
Proportion of non-responders participants at day 7 of 40 mg twice daily chewable ASA regimen, 81 mg twice daily EC ASA regimen and 162 mg once daily EC ASA regimen.
Time Frame: 1 year
|
Hypothesis: The 40 mg twice daily chewable ASA regimen will be associated with the lowest proportion of non-responders.
|
1 year
|
For the run-in phase, characterize the prevalence of ASA non-responders at steady state following a 7-day treatment with ASA EC 81 mg once daily in participants with type 2 diabetes.
Time Frame: 1 year
|
Hypothesis: at least 10-15 percent of participants will be non-responders after taking EC ASA 81 mg die for 7 days.
|
1 year
|
Proportion of participants who are non-responders to ASA with each dose as measured by serum levels of thromboxane B2 (TxB2).
Time Frame: 1 year
|
Non-resposne to ASA as measured by serum levels of thromboxane B2 (TxB2).
|
1 year
|
Platelet response levels to various agonists not directly related to the pharmacological target of ASA, including ADP, collagen, epinephrine and thrombin receptor-activating peptide (TRAP).
Time Frame: 1 year
|
Non-response to ASA as measured with ADP, collagen, epinephrine and thrombin receptor-activating peptide (TRAP).
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guillaume Marquis Gravel, MD, MSc, ICM Co. Ltd.
Publications and helpful links
General Publications
- Marquis-Gravel G, Roe MT, Harrington RA, Munoz D, Hernandez AF, Jones WS. Revisiting the Role of Aspirin for the Primary Prevention of Cardiovascular Disease. Circulation. 2019 Sep 24;140(13):1115-1124. doi: 10.1161/CIRCULATIONAHA.119.040205. Epub 2019 Sep 23.
- ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1529-1539. doi: 10.1056/NEJMoa1804988. Epub 2018 Aug 26.
- Lordkipanidze M, Pharand C, Schampaert E, Palisaitis DA, Diodati JG. Heterogeneity in platelet cyclooxygenase inhibition by aspirin in coronary artery disease. Int J Cardiol. 2011 Jul 1;150(1):39-44. doi: 10.1016/j.ijcard.2010.02.025. Epub 2010 Mar 7.
- Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- ICM 2023-3231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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