ANTITHROMBOTIC THERAPY IN THE DIABETIC PATIENT: STUDY ON THE EFFECT ON PLATELET FUNCTIONALITY OF A GREATER DOSAGE OF ASPIRIN OR THE ASSOCIATION OF LOW DOSES OF ASPIRIN PLUS SELECTIVE INHIBITOR OF THE COX-2 - ND

• Conditions: PRIMARY PREVENTION ON MELLITUS DIABETES NIDDM; MedDRA version: 6.1Level: PTClassification code 10061815

• Registration Number: EUCTR2007-003376-20-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-TYPE 2 DIABETES
-AGE 40-60 YEARS
-CHRONIC TREATMENT WITH ASA 75-100 MG
-LOW CARDIOVASCULARE RISK (LESS THAN 10% ACCORDING TO THE RISK SCORE OF ISTITUTO SUPERIORE SANITa')
-NO PREVIOUS CARDIOVASCULAR EVENTS
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-GASTROINTESTINAL BLEEDING
- RENAL FAILURE
- SEVERE LIVER FAILURE
- INTESTINAL BOWL DISEASE
-CONGESTIVE HEART FAILURE (NIHA 3-4)
- HYPERTENSION
- ANTICOAGULANT THERAPY
-THROMBOCITOSI, THROMBOCITOPENIA, POLICITEMIA

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO DEMONSTRATE A EVENTUAL MAJOR EFFECT OF THE ASSOCIATION OF LOW DOSES OF ASPIRIN PLUS SELECTIVE INHIBITOR OF THE COX-2 VS ASPIRIN ALONE IN REDUCING PLATELET AGGREGATION AND TXA2 PRODUCTION IN PRIMARY PREVENTION OF PATIENTS WITH TYPE II DIABETES;Secondary Objective: TO INVESTIGATE IN VITRO PLATELET AGGREGATION IN BOTH GROUPS OF PATIENTS;Primary end point(s): DECREASING ON PLATELET AGGREGATION AND TXA2 LEVELS.