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

Phase 4

Completed

• Conditions: Diabetes Mellitus; Acute Coronary Syndrome
• Interventions: Drug: aspirin 100 mg once daily; Drug: aspirin 100 mg bis in die; Drug: aspririn 200 mg once daily

• Registration Number: NCT05293808
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2014-10-01
• Study Completion: 2016-01-01
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspririn 100 mg	aspirin 100 mg once daily	aspirin 100 mg once daily
aspirin 100 mg bis in die	aspirin 100 mg bis in die	aspirin 100 mg twice daily for the first month after acute coronary syndrome
aspirin 200 mg	aspririn 200 mg once daily	aspirin 200 mg once daily for the first month after acute coronary syndrome

Primary Outcome Measures

Name	Time	Method
Effects of different doses of aspirin on platelet aggregation	1 month	Valuation of different doses of aspirin once or twice daily on platelet aggregation after 10 day and 30 day from the acute coronary syndrome

Secondary Outcome Measures

Name	Time	Method
Valuation of RAC1 levels in platelets	1 month

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Naples, Italy