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

NCT05293808 | Completed Phase 4

• 1 other identifier: 8/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

platelet aggregation; acute coronary syndrome; diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Valuation of RAC1 levels in platelets

  1 month

Study Arms (3)

aspirin 100 mg bis in die

EXPERIMENTAL

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

Drug: aspirin 100 mg bis in die

aspirin 200 mg

ACTIVE COMPARATOR

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

Drug: aspririn 200 mg once daily

aspririn 100 mg

ACTIVE COMPARATOR

aspirin 100 mg once daily

Drug: aspirin 100 mg once daily

Interventions

aspirin 100 mg bis in die DRUG

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

aspirin 100 mg bis in die

aspririn 200 mg once daily DRUG

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

aspirin 200 mg

aspirin 100 mg once daily DRUG

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

aspririn 100 mg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients with acute coronary syndrome after 24 hours from the coronarography

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Diabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2016
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

IT (1)