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

February 22, 2024 updated by: Giovanni Esposito, Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of different doses of aspirin on platelet aggregation
Time Frame: 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
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Valuation of RAC1 levels in platelets
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on aspirin 100 mg bis in die

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe