Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin (DIABE-ASACS)

Federico II University

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome; Diabetes Mellitus

Treatments: Drug: aspririn 200 mg once daily; Drug: aspirin 100 mg once daily; Drug: aspirin 100 mg bis in die

Study type: Interventional

Funder types: Other

Identifiers

NCT05293808

8/14

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

aspirin 100 mg bis in die

Experimental group

Description:

aspirin 100 mg twice daily for the first month after acute coronary syndrome

Treatment:

Drug: aspirin 100 mg bis in die

aspirin 200 mg

Active Comparator group

Description:

aspirin 200 mg once daily for the first month after acute coronary syndrome

Treatment:

Drug: aspririn 200 mg once daily

aspririn 100 mg

Active Comparator group

Description:

aspirin 100 mg once daily

Treatment:

Drug: aspirin 100 mg once daily