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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01935193
Other study ID # ASAR160
Secondary ID
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
Health authority
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. completion date
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

Study Design


Related Conditions & MeSH terms


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
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