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Aspirin Resistance Reversibility in Diabetic Patients

Phase 4
Conditions
Aspirin Resistance
Interventions
Registration Number
NCT01935193
Lead Sponsor
Azienda Ospedaliera San Giovanni Battista
Brief Summary

The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
160
Inclusion Criteria
  • diabete mellitus type 2
  • asa since 30 days at least
  • plts >150000 and <450000
Exclusion Criteria
  • recent ACS (within 30 days)
  • anticoagulant therapy
  • haemorragic diathesis

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
asa resistantlysine acetylsalicylateasa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate.
Primary Outcome Measures
NameTimeMethod
platelets aggregation assessed by two tests (PFA100 and VerifyNow)24 hours

diabetic patients found aspirin resistant receive and infusion of 288 mg of lysine acetylsalicylate and they are tested again 24 h after the infusion to investigate if aspirin resistance have been reversed.

Secondary Outcome Measures
NameTimeMethod
stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate1 month

Trial Locations

Locations (1)

San Giovanni Battista Hospital

🇮🇹

Torino, Italy

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