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

NCT ID: NCT05293808

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2016-01-01

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aspirin 100 mg bis in die

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

Group Type: EXPERIMENTAL

aspirin 100 mg bis in die

Intervention Type: DRUG

Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

aspirin 200 mg

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

Group Type: ACTIVE_COMPARATOR

aspririn 200 mg once daily

Intervention Type: DRUG

Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

aspririn 100 mg

aspirin 100 mg once daily

Group Type: ACTIVE_COMPARATOR

aspirin 100 mg once daily

Intervention Type: DRUG

Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

Interventions

aspirin 100 mg bis in die

Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

Intervention Type: DRUG

aspririn 200 mg once daily

Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

Intervention Type: DRUG

aspirin 100 mg once daily

Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Esposito

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Federico II

Naples, , Italy

Countries

Italy

Other Identifiers

8/14

Identifier Type: -

Identifier Source: org_study_id