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

Diabetes Mellitus Clinical Trial

— DIABE-ASACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293808
• Other study ID #: 8/14
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2014
• Est. completion date: January 1, 2016

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2016
• Est. primary completion date: October 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Syndrome

Intervention

Drug:
• aspirin 100 mg bis in die
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
• aspririn 200 mg once daily
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
• aspirin 100 mg once daily
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Valuation of RAC1 levels in platelets		1 month