COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Aspirin Resistance Reversibility in Diabetic Patients (ARRDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01935193

Layout table for location contacts
Contact: Marta Bisi, MD +393476985414

Layout table for location information
San Giovanni Battista Hospital Recruiting
Torino, Italy
Contact: Marta Bisi, MD    +393476985414   
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Layout table for additonal information
Responsible Party: Marta Bisi, MD, Azienda Ospedaliera San Giovanni Battista Identifier: NCT01935193    
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:
Layout table for MeSH terms
Acetylsalicylic acid lysinate
Platelet Aggregation Inhibitors
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action