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New treatment option for Platelet Aggregation
Official title Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
ClinicalTrials.gov ID: NCT05702463
What this study is testing
What is Aspirin 81Mg Ec Tab twice daily for 7 days?
Aspirin 81Mg Ec Tab twice daily for 7 days is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for platelet aggregation.
Also referred to as ASA 81 mg EC Tab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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);
You likely can't join if
- 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;
See the full eligibility 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 assigned by chance phases of the trial.
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.