Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 1317 for:    ASPIRIN AND Platelet Aggregation

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.
 
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

Tracking Information
First Submitted Date  ICMJE August 28, 2013
First Posted Date  ICMJE September 5, 2013
Last Update Posted Date September 5, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Resistance Reversibility in Diabetic Patients
Official Title  ICMJE Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aspirin Resistance
Intervention  ICMJE Drug: lysine acetylsalicylate
Other Names:
  • Flectadol
  • Cardirene
Study Arms  ICMJE 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.
Intervention: Drug: lysine acetylsalicylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 30, 2013)
160
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01935193
Other Study ID Numbers  ICMJE ASAR160
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marta Bisi, Azienda Ospedaliera San Giovanni Battista
Study Sponsor  ICMJE Azienda Ospedaliera San Giovanni Battista
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliera San Giovanni Battista
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP