Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin

Study Overview
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Brief Summary
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Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.

Official Title
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Evaluation of Different Doses of Aspirin on Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome

Conditions
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Diabetes Mellitus, Acute Coronary Syndrome

Intervention / Treatment
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* Drug: aspirin 100 mg bis in die
* Drug: aspririn 200 mg once daily
* Drug: aspirin 100 mg once daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients with acute coronary syndrome after 24 hours from the coronarography Exclusion Criteria: patients with a family or personal history of bleeding or thrombophilic disorders; platelet count >600000/mmc or <150000/mmc hematocrit >50% or <25% creatinine clearance <30 mL/min

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin 100 mg bis in die<br>aspirin 100 mg twice daily for the first month after acute coronary syndrome | Drug: aspirin 100 mg bis in die<br>* Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.<br>|
| Active Comparator: aspirin 200 mg<br>aspirin 200 mg once daily for the first month after acute coronary syndrome | Drug: aspririn 200 mg once daily<br>* Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.<br>|
| Active Comparator: aspririn 100 mg<br>aspirin 100 mg once daily | Drug: aspirin 100 mg once daily<br>* Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of different doses of aspirin on platelet aggregation | Valuation of different doses of aspirin once or twice daily on platelet aggregation after 10 day and 30 day from the acute coronary syndrome | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valuation of RAC1 levels in platelets |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet aggregation, acute coronary syndrome, diabetes