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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05293808
Other study ID # 8/14
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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