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OpenTrials
Completed

NCT Number: NCT05293808

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aspirin 100 mg bis in die

Drug

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

aspririn 200 mg once daily

Drug

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

aspirin 100 mg once daily

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Valuation of RAC1 levels in platelets

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: DIABE-ASACS

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Mar 24, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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