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Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization (RAP)

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ClinicalTrials.gov Identifier: NCT03953547
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:
In coronary pathology, persistent platelet hyperresponsiveness under antiplatelet therapy, which is often referred to as "antiplatelet resistance," is predictive of increased risk of thrombotic recurrence as well as hyper-Inhibition of this aggregation may be predictive of a hemorrhagic risk. But no study has shown that the adaptation of treatment based on platelet aggregation tests has a benefit: the management of antiplatelet treatments through the search for antiplatelet resistance (APR) is not recommended by the European Society of Cardiology (ESC) in the context of coronary angioplasty (IIIA), while this is a common practice in neurovascular pathology.

Condition or disease
Vascular Diseases

Detailed Description:
In peripheral arterial disease, several studies have shown that the existence of an APR is predictive of the occurrence of thrombotic events but not all. The investigators can therefore ask the question of the benefit of adaptation of antiplatelet therapy by biological monitoring to prevent the recurrence of thrombotic events. The platelet aggregation tests used mainly concern aspirin, via stimulation with arachidonic acid, or anti-P2Y12 (clopidogrel, ticagrelor, prasugrel), via stimulation with adenosine diphosphate (ADP). For the latter, a test via the measurement of the phosphorylation of a cytoplasmic protein called "VASP" is also used routinely, making it possible to further clarify the existence of platelet resistance to anti-P2Y12. Within the vascular medicine department, any discovery of a potential resistance to the anti-platelet treatment of a patient requires a therapeutic adaptation to overcome this phenomenon of "resistance", and to improve the phenomenon of anti-aggregation

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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 31, 2018

Group/Cohort
search for antiplatelet resistance
Patients who were hospitalized in the vascular medicine department and who benefited from a search for antiplatelet resistance between April 2014 and November 2017.



Primary Outcome Measures :
  1. Number of re-occlusion of the revascularization procedure [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of cardiovascular events [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were hospitalized in the vascular medicine department and who received a search for antiplatelet resistance between April 2014 and November 2017.
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • All patients who were hospitalized in the vascular medicine department and who received a search for antiplatelet resistance between April 2014 and November 2017.

Exclusion Criteria:

  • Opposition to participation in the study
  • Absence of follow-up after antiplatelet resistance testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953547


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Raphaël ATTAL, MD Groupe Hospitalier Paris Saint Joseph

Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03953547     History of Changes
Other Study ID Numbers: RAP
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Groupe Hospitalier Paris Saint Joseph:
antiplatelet resistance
peripheral arterial revascularization

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases