Clinical trial

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

Name

8/14

Description

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.

Trial arms

Trial start

2014-05-01

Estimated PCD

2014-10-01

Trial end

2016-01-01

Status

Completed

Phase

Early phase I

Treatment

aspirin 100 mg bis in die

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

Arms:

aspirin 100 mg bis in die

aspririn 200 mg once daily

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

Arms:

aspirin 200 mg

aspirin 100 mg once daily

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

Arms:

aspririn 100 mg

Size

Primary endpoint

Effects of different doses of aspirin on platelet aggregation

1 month

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-02-23

1 organization

1 product

2 indications

Organization

Federico II University

Product

Aspirin

Indication

Acute Coronary Syndrome

Indication

Diabetes Mellitus