Aspirin Resistance Reversibility in Diabetic Patients (ARRDM)

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

Tracking Information

• First Submitted Date: August 28, 2013
• First Posted Date: September 5, 2013
• Last Update Posted Date: September 5, 2013
• Study Start Date: November 2011
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Aspirin Resistance Reversibility in Diabetic Patients
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Aspirin Resistance

Intervention

Drug: lysine acetylsalicylate

Other Names:

• Flectadol
• Cardirene

Study Arms

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 30, 2013): 160
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01935193
• Other Study ID Numbers: ASAR160
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Marta Bisi, Azienda Ospedaliera San Giovanni Battista
• Study Sponsor: Azienda Ospedaliera San Giovanni Battista
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Azienda Ospedaliera San Giovanni Battista
• Verification Date: August 2013