Aspirin Resistance Reversibility in Diabetic Patients

Aspirin Resistance Clinical Trial

— ARRDM  

Official title:

Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01935193
• Other study ID #: ASAR160
• Status: Unknown status
• Phase: Phase 4
• First received: August 28, 2013
• Last updated: August 30, 2013
• Start date: November 2011

Study information

• Verified date: August 2013
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: Marta Bisi, MD
• Phone: +393476985414
• Email: martadoro[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 160
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspirin Resistance

Intervention

Drug:
• lysine acetylsalicylate

Locations

Country	Name	City	State
Italy	San Giovanni Battista Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelets aggregation assessed by two tests (PFA100 and VerifyNow)	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.	24 hours
Secondary	stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate		1 month