NCT01935193

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
Last Updated

September 5, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

August 28, 2013

Last Update Submit

August 30, 2013

Conditions

Aspirin Resistance

Keywords

platelets aggregationasa resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate

    1 month

Study Arms (1)

asa resistant

EXPERIMENTAL

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

Interventions

lysine acetylsalicylateDRUG
Also known as: Flectadol, Cardirene
asa resistant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabete mellitus type 2
  • asa since 30 days at least
  • plts \>150000 and \<450000

You may not qualify if:

  • recent ACS (within 30 days)
  • anticoagulant therapy
  • haemorragic diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Battista Hospital

Torino, Italy

RECRUITING

MeSH Terms

Interventions

acetylsalicylic acid lysinate

Central Study Contacts

Marta Bisi, MD

CONTACT

+393476985414martadoro@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 5, 2013

Study Start

November 1, 2011

Primary Completion

August 1, 2013

Last Updated

September 5, 2013

Record last verified: 2013-08

Locations

IT(1)