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ARRDM: Aspirin Resistance Reversibility in Diabetic Patients

Sponsor
Azienda Ospedaliera San Giovanni Battista (Other)
Overall Status
Unknown status
CT.gov ID
NCT01935193
Collaborator
(none)
160
Enrollment
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: lysine acetylsalicylate
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: asa resistant

asa 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.

Drug: lysine acetylsalicylate
Other Names:
  • Flectadol
  • Cardirene

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Giovanni Battista Hospital Torino Italy

    Sponsors and Collaborators

    • Azienda Ospedaliera San Giovanni Battista

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marta Bisi, MD, Azienda Ospedaliera San Giovanni Battista
    ClinicalTrials.gov Identifier:
    NCT01935193
    Other Study ID Numbers:
    • ASAR160
    First Posted:
    Sep 5, 2013
    Last Update Posted:
    Sep 5, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Marta Bisi, MD, Azienda Ospedaliera San Giovanni Battista
    platelets aggregation
    asa resistance
    Additional relevant MeSH terms:
    Acetylsalicylic acid lysinate

    Study Results

    No Results Posted as of Sep 5, 2013