Platelet AggregationPhase 1APPEASEDIINCT05702463
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
A Phase 1 study testing Aspirin 81Mg Ec Tab twice daily for 7 days, Aspirin 40Mg Chew Tab twice daily for 7 days and Aspirin 162 mg EC Tab once daily for 7 days in people with Platelet Aggregation and Type 2 Diabetes, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Aggregation, Type 2 Diabetes, Aspirin
- What is being tested?
- Aspirin 81Mg Ec Tab twice daily for 7 days, Aspirin 40Mg Chew Tab twice daily for 7 days and Aspirin 162 mg EC Tab once daily for 7 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jun 2023to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guillaume Marquis Gravel, MD, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Guillaume Marquis-Gravel, MD
About this study
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.
Read the detailed description
APPEASED II is a triple crossover, open-label, randomized controlled pilot trial preceded by a 7-day run in period, aiming to determine the feasibility of a larger confirmatory randomized trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization of EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily in patients with type 2 diabetes.The primary endpoint will be to determine, among initial ASA non-responder participants in the run-in phase, the proportion of participants that remain ASA non-responders with different formulations and dosing regimens of ASA, including EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The incomplete platelet aggregation will be evaluated by the response to arachidonic acid at a concentration of 1mM, measured by LTA (Light Transmission Aggregometry). For every platelet function assessment, serum salicylate concentration will also be measured. Upon the screening visit (day 0), blood will be drawn and baseline platelet function will be assessed. A 7 day supply of aspirin will be given to participants meeting the eligibility criteria. Participants will be instructed to take 1 dose of 80 mg of enteric coated aspirin per day at the same time every day. Upon day 7, participants will return for a second visit before the intake of their daily aspirin, and therefore 24 hours after the previous dose of aspirin was taken. Blood will be drawn and platelet function will be assessed in the same manner as described previously. Participants will then take their 7th dose of aspirin under supervision, and a blood sample will be collected and platelet function will be assessed two hours later. If participants have an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily, they 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. These participants will receive the pillbox containing the first assigned regimen on this visit. The 3 study arms and the run-in phase will last 7 days each, with at least 7 days of wash-out between each arm. To accommodate participants with busy schedules and to minimize follow-up losses, a longer washout period will be tolerated if the participant is unable to return to the research center after 14 days. At every visit of the randomized portion of the trial, participants will leave with the next 6-day ASA regimen in a pillbox, that is 6 doses for the once daily regimen and 13 doses for the twice daily regimens. On day 7 of all three study arms, patients will be questioned about medication adherence with the presence of the participant's pillbox. Two blood samples will be collected, one 24 hours after the last dose and one 2 hours after taking the last dose in front of the investigators. The platelet aggregation inhibition with arachidonic acid and platelet reactivity to various agonists will be assessed by LTA. Serum levels of TxB2 will also be assessed.
- Conditions
- Platelet Aggregation, Type 2 Diabetes, Aspirin, Diabetes Mellitus, Type 2, Platelet Aggregation Inhibitors
- Being tested
- Aspirin 81Mg Ec Tab twice daily for 7 days, Aspirin 40Mg Chew Tab twice daily for 7 days, Aspirin 162 mg EC Tab once daily for 7 days
- Keywords
- diabetes, aspirin, Acetylsalicylic acid, Pharmacodynamics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81Mg Ec Tab twice daily for 7 daysDrug
Also called ASA 81 mg EC Tab
Participants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.
Aspirin 40Mg Chew Tab twice daily for 7 daysDrug
Also called ASA 40 mg Chew Tab
Participants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.
Aspirin 162 mg EC Tab once daily for 7 daysDrug
Also called ASA 162 mg EC Tab
Participants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| EC ASA 162 mg once daily for 7 days | Experimental | EC ASA 162 mg once daily for 7 days Receives: Drug: Aspirin 162 mg EC Tab once daily for 7 days |
| EC ASA 81 mg twice daily for 7 days | Experimental | EC ASA 81 mg twice daily for 7 days Receives: Drug: Aspirin 81Mg Ec Tab twice daily for 7 days |
| chewable ASA 40 mg twice daily for 7 days | Experimental | chewable ASA 40 mg twice daily for 7 days Receives: Drug: Aspirin 40Mg Chew Tab twice daily for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the screening rate to evaluate the feasibility of a larger scale randomized controlled trial.
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
Measured: 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.
Hypothesis : at least 70 percent of referred patients will be eligible
Measured: 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.
Hypothesis : At least 40 percent of eligible patients will give their consent to participate in the run-in phase and the study
Measured: 1 year
Describe the retention rate to evaluate the feasibility of a larger scale randomized controlled trial.
Determine the retention rate of randomized participants
Hypothesis : at least 85 percent of all randomized subjects will complete all study visits
Measured: 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.
Hypothesis : in at least one of the regimens studied, the proportion of ASA non-responders will be less than 50 percent.
Measured: 1 year
Secondary outcomes (6)
Adherence rate to study protocol
Hypothesis : At least 90 percent of participants will be adherent to all study doses.
Measured: 1 year
Average time per participant required to complete study enrolment and all data collection.
Endpoints :
Average time required to screen for, consent and enroll per participant and average time to complete study procedures and data collection per participant
Measured: 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.
Hypothesis: The 40 mg twice daily chewable ASA regimen will be associated with the lowest proportion of non-responders.
Measured: 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.
Hypothesis: at least 10-15 percent of participants will be non-responders after taking EC ASA 81 mg die for 7 days.
Measured: 1 year
Proportion of participants who are non-responders to ASA with each dose as measured by serum levels of thromboxane B2 (TxB2).
Non-resposne to ASA as measured by serum levels of thromboxane B2 (TxB2).
Measured: 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).
Non-response to ASA as measured with ADP, collagen, epinephrine and thrombin receptor-activating peptide (TRAP).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start13 Jun 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet AggregationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- triple crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Guillaume Marquis Gravel, MD, MSc, Principal investigator, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702463
- Sponsor's protocol ID
- ICM 2023-3231
- Acronym
- APPEASEDII
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31545683ASCEND 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.
PubMed 30146931Lordkipanidze 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.
PubMed 20207433Bhatt 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.
PubMed 28089180
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
- ClinicalTrials.gov ID
- NCT05702463
- Acronym / sponsor ID
- APPEASEDII / ICM 2023-3231
- Conditions
- Platelet Aggregation, Type 2 Diabetes, Aspirin, Diabetes Mellitus, Type 2, Platelet Aggregation Inhibitors
- Keywords
- diabetes, aspirin, Acetylsalicylic acid, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
APPEASED II is a triple crossover, open-label, randomized controlled pilot trial preceded by a 7-day run in period, aiming to determine the feasibility of a larger confirmatory randomized trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization of EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily in patients with type 2 diabetes.The primary endpoint will be to determine, among initial ASA non-responder participants in the run-in phase, the proportion of participants that remain ASA non-responders with different formulations and dosing regimens of ASA, including EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The incomplete platelet aggregation will be evaluated by the response to arachidonic acid at a concentration of 1mM, measured by LTA (Light Transmission Aggregometry). For every platelet function assessment, serum salicylate concentration will also be measured. Upon the screening visit (day 0), blood will be drawn and baseline platelet function will be assessed. A 7 day supply of aspirin will be given to participants meeting the eligibility criteria. Participants will be instructed to take 1 dose of 80 mg of enteric coated aspirin per day at the same time every day. Upon day 7, participants will return for a second visit before the intake of their daily aspirin, and therefore 24 hours after the previous dose of aspirin was taken. Blood will be drawn and platelet function will be assessed in the same manner as described previously. Participants will then take their 7th dose of aspirin under supervision, and a blood sample will be collected and platelet function will be assessed two hours later. If participants have an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily, they 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. These participants will receive the pillbox containing the first assigned regimen on this visit. The 3 study arms and the run-in phase will last 7 days each, with at least 7 days of wash-out between each arm. To accommodate participants with busy schedules and to minimize follow-up losses, a longer washout period will be tolerated if the participant is unable to return to the research center after 14 days. At every visit of the randomized portion of the trial, participants will leave with the next 6-day ASA regimen in a pillbox, that is 6 doses for the once daily regimen and 13 doses for the twice daily regimens. On day 7 of all three study arms, patients will be questioned about medication adherence with the presence of the participant's pillbox. Two blood samples will be collected, one 24 hours after the last dose and one 2 hours after taking the last dose in front of the investigators. The platelet aggregation inhibition with arachidonic acid and platelet reactivity to various agonists will be assessed by LTA. Serum levels of TxB2 will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- triple crossover
| Arm | Type | Receives |
|---|---|---|
| EC ASA 162 mg once daily for 7 days | Experimental | Drug: Aspirin 162 mg EC Tab once daily for 7 daysEC ASA 162 mg once daily for 7 days |
| EC ASA 81 mg twice daily for 7 days | Experimental | Drug: Aspirin 81Mg Ec Tab twice daily for 7 daysEC ASA 81 mg twice daily for 7 days |
| chewable ASA 40 mg twice daily for 7 days | Experimental | Drug: Aspirin 40Mg Chew Tab twice daily for 7 dayschewable ASA 40 mg twice daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- Willing to attend all study visits of both the run-in and randomized phases of the trial.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81Mg Ec Tab twice daily for 7 daysAlso: ASA 81 mg EC TabParticipants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days. | Drug | EC ASA 81 mg twice daily for 7 days |
| Aspirin 40Mg Chew Tab twice daily for 7 daysAlso: ASA 40 mg Chew TabParticipants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days. | Drug | chewable ASA 40 mg twice daily for 7 days |
| Aspirin 162 mg EC Tab once daily for 7 daysAlso: ASA 162 mg EC TabParticipants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days. | Drug | EC ASA 162 mg once daily for 7 days |
Primary outcome
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
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
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
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
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.
6 secondary outcomes
Adherence rate to study protocol
Time frame: 1 year
Average time per participant required to complete study enrolment and all data collection.
Time frame: 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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 31545683Marquis-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.
- Background: PubMed 30146931ASCEND 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.
- Background: PubMed 20207433Lordkipanidze 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.
- Background: PubMed 28089180Bhatt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Marquis Gravel, MD, MSc contact
Guillaume Marquis Gravel, MD, MSc principal investigator
ICM Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aspirin 81Mg Ec Tab twice daily for 7 days, Aspirin 40Mg Chew Tab twice daily for 7 days and Aspirin 162 mg EC Tab once daily for 7 days in people with Platelet Aggregation and Type 2 Diabetes, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Marquis Gravel, MD, MSc (514-376-3330 ext. ext 3635, guillaume.marquis.gravel@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the screening rate to evaluate the feasibility of a larger scale randomized controlled trial. (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702463, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.