[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493231":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":74,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":73,"enrollmentInfo":88,"targetDuration":73,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":101,"overallStatus":58,"whyStopped":73,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Montreal Heart Institute","OTHER",[8,13,17],{"label":9,"type":10,"description":9,"interventionNames":11},"EC ASA 162 mg once daily for 7 days","EXPERIMENTAL",[12],"Drug: Aspirin 162 mg EC Tab once daily for 7 days",{"label":14,"type":10,"description":14,"interventionNames":15},"EC ASA 81 mg twice daily for 7 days",[16],"Drug: Aspirin 81Mg Ec Tab twice daily for 7 days",{"label":18,"type":10,"description":18,"interventionNames":19},"chewable ASA 40 mg twice daily for 7 days",[20],"Drug: Aspirin 40Mg Chew Tab twice daily for 7 days",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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.",[14],[28],"ASA 81 mg EC Tab",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[18],[34],"ASA 40 mg Chew Tab",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"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.",[9],[40],"ASA 162 mg EC Tab",[42],{"name":43,"affiliation":44,"role":45},"Guillaume Marquis Gravel, MD, MSc","ICM Co. Ltd.","PRINCIPAL_INVESTIGATOR",[47,52],{"name":43,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","514-376-3330","ext 3635","guillaume.marquis.gravel@umontreal.ca",{"name":53,"role":48,"phone":49,"phoneExt":54,"email":55},"Marie Lordkipanidzé B. Pharm, Ph.D.","2694","marie.lordkipanidze@umontreal.ca",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Montreal","Quebec","H1T 1C8","Canada","CA",{"type":65,"coordinates":66},"Point",[67,68],-73.58781,45.50884,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":73,"phoneExt":73,"email":73},"Guillaume Marquis-Gravel, MD",null,{"type":75,"investigatorFullName":73,"investigatorTitle":73,"investigatorAffiliation":73,"oldNameTitle":73,"oldOrganization":73},"SPONSOR",[77],{"name":78,"class":6},"Heart and Stroke Foundation of Canada","100493231","phase-1-assessing-pharmacokinetics-and-pharmacodynamics-of-daily-enteric-coated-aspirin-in-patients-with-stable-diabetes-ii-100493231",false,"NCT05702463","Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II","APPEASEDII","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. 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;\n3. Type 2 diabetes, based on at least one of the following criteria: (5)\n\n   * Chronic treatment with oral antihyperglycemic agents or insulin therapy;\n   * Fasting Plasma Glucose (FPG) ≥ 126 mg\u002FdL (7.0 mmol\u002FL) (fasting is defined as no caloric intake for at least 8h);\n   * 2-h Plasma Glucose (2h-PG) ≥ 200 mg\u002FdL (11.1 mmol\u002FL) during the oral glucose tolerance test (OGTT);\n   * A1C ≥ 6.5% (48 mmol\u002Fml);\n4. Willing to attend all study visits of both the run-in and randomized phases of the trial.\n\nExclusion Criteria:\n\n1. Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;\n2. Known hypersensitivity to ASA;\n3. Patient requiring dialysis;\n4. Severe hepatic insufficiency or ALT \\> 3 x ULN;\n5. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;\n6. Bleeding diathesis;\n7. Platelet count or hemoglobin levels outside of the normal reference range;\n8. Planned major surgical procedure or dental procedure during the course of the study;\n9. Chronic inflammatory disease requiring regular anti-inflammatory treatment;\n10. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;\n11. Active cancer;\n12. History of hematological malignancy or myelodysplasia;\n13. Pregnant or lactating women;","ALL","18 Years",{"count":89,"type":90},30,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","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.",[96,97,98,99,100],"Platelet Aggregation","Type 2 Diabetes","Aspirin","Diabetes Mellitus, Type 2","Platelet Aggregation Inhibitors",[102,103,104,105],"diabetes","aspirin","Acetylsalicylic acid","Pharmacodynamics","2025-12-02",{"date":108,"type":109},"2025-12-03","ACTUAL",{"date":111,"type":109},"2023-06-13",{"date":113,"type":90},"2027-07-01",{"name":5,"class":6},1]