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Trial record 31 of 1293 for:    ASPIRIN AND Platelet Aggregation

Aspirin Resistance Reversibility in Diabetic Patients (ARRDM)

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ClinicalTrials.gov Identifier: NCT01935193
Recruitment Status : Unknown
Verified August 2013 by Marta Bisi, Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Recruiting
First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
Marta Bisi, 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.

Condition or disease Intervention/treatment Phase
Aspirin Resistance Drug: lysine acetylsalicylate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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 : November 2011
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. platelets aggregation assessed by two tests (PFA100 and VerifyNow) [ Time Frame: 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 [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935193


Contacts
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Contact: Marta Bisi, MD +393476985414 martadoro@hotmail.com

Locations
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Italy
San Giovanni Battista Hospital Recruiting
Torino, Italy
Contact: Marta Bisi, MD    +393476985414    martadoro@hotmail.com   
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista

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Responsible Party: Marta Bisi, MD, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier: NCT01935193     History of Changes
Other Study ID Numbers: ASAR160
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: August 2013
Keywords provided by Marta Bisi, Azienda Ospedaliera San Giovanni Battista:
platelets aggregation
asa resistance
Additional relevant MeSH terms:
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Aspirin
Acetylsalicylic acid lysinate
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics