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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003376-20-IT
Enrollment
Unknown
Registered
2008-01-04
Start date
2008-09-23
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PRIMARY PREVENTION ON MELLITUS DIABETES NIDDM MedDRA version: 6.1 Level: PT Classification code 10061815

Interventions

Trade Name: ARCOXIA Pharmaceutical Form: Coated tablet INN or Proposed INN: Etoricoxib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Trade Name: ASPIRINETTA

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026