Comparing 3 approaches for platelet aggregation
Official title: Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
- Phase 1
- 3 groups
- One site, in Montreal
- Recruiting
Interventions
- Medication
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.
- Medication
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.
- Medication
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → phases of the trial.
Exclusion
- −Known hypersensitivity to ASA;
- −Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
- −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;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Aspirin 162 mg EC Tab once daily for 7 days.
Registry label: A: EC ASA 162 mg once daily for 7 days
Group B receives Aspirin 81Mg Ec Tab twice daily for 7 days.
Registry label: B: EC ASA 81 mg twice daily for 7 days
Group C receives Aspirin 40Mg Chew Tab twice daily for 7 days.
Registry label: C: chewable ASA 40 mg twice daily for 7 days
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Describe the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → rate to evaluate the feasibility of a larger scale randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → controlled trial — measured over 1 year.
Describe the enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → rate by the proportion of referred participants who are eligible to evaluate the feasibility of a larger scale randomized controlled trial — measured over 1 year.
Describe the enrollment rate by the proportion of eligible participants who consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to evaluate the feasibility of a larger scale randomized controlled trial — measured over 1 year.
Describe the retention rate to evaluate the feasibility of a larger scale randomized controlled trial — measured over 1 year.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05702463 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Aspirin 81Mg Ec Tab twice daily for 7 daysDrug
Participants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Aspirin 40Mg Chew Tab twice daily for 7 daysDrug
Participants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Aspirin 162 mg EC Tab once daily for 7 daysDrug
Participants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2027-07-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.