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出境医 / 临床实验 / Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization (RAP)

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

Study Description
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
Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Principal Investigator: Raphaël ATTAL, MD Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 16, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date January 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019) 		Number of re-occlusion of the revascularization procedure [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2019) 		Number of cardiovascular events [ Time Frame: 1 year ]
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 Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization
Official Title Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization
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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Vascular Diseases
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *
  • Siller-Matula JM, Delle-Karth G, Lang IM, Neunteufl T, Kozinski M, Kubica J, Maurer G, Linkowska K, Grzybowski T, Huber K, Jilma B. Phenotyping vs. genotyping for prediction of clopidogrel efficacy and safety: the PEGASUS-PCI study. J Thromb Haemost. 2012 Apr;10(4):529-42. doi: 10.1111/j.1538-7836.2012.04639.x.
  • Pinto Slottow TL, Bonello L, Gavini R, Beauzile P, Sushinsky SJ, Scheinowitz M, Kaneshige K, Xue Z, Torguson R, Tantry U, Pichard AD, Satler LF, Suddath WO, Kent K, Gurbel P, Waksman R. Prevalence of aspirin and clopidogrel resistance among patients with and without drug-eluting stent thrombosis. Am J Cardiol. 2009 Aug 15;104(4):525-30. doi: 10.1016/j.amjcard.2009.04.015. Epub 2009 Jun 24.
  • Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Jüni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419.
  • Gupta R, Moore JM, Griessenauer CJ, Adeeb N, Patel AS, Youn R, Poliskey K, Thomas AJ, Ogilvy CS. Assessment of Dual-Antiplatelet Regimen for Pipeline Embolization Device Placement: A Survey of Major Academic Neurovascular Centers in the United States. World Neurosurg. 2016 Dec;96:285-292. doi: 10.1016/j.wneu.2016.09.013. Epub 2016 Sep 15.
  • Mazur P, Frołow M, Niżankowski R, Sadowski J, Undas A. Impaired responsiveness to clopidogrel and aspirin in patients with recurrent stent thrombosis following percutaneous intervention for peripheral artery disease. Platelets. 2013;24(2):151-5. doi: 10.3109/09537104.2012.676220. Epub 2012 Apr 13.
  • Mueller MR, Salat A, Stangl P, Murabito M, Pulaki S, Boehm D, Koppensteiner R, Ergun E, Mittlboeck M, Schreiner W, Losert U, Wolner E. Variable platelet response to low-dose ASA and the risk of limb deterioration in patients submitted to peripheral arterial angioplasty. Thromb Haemost. 1997 Sep;78(3):1003-7.
  • Kasotakis G, Pipinos II, Lynch TG. Current evidence and clinical implications of aspirin resistance. J Vasc Surg. 2009 Dec;50(6):1500-10. doi: 10.1016/j.jvs.2009.06.023. Epub 2009 Aug 12. Review.
  • Doly JS, Lorian E, Desormais I, Constans J, Bura Rivière A, Lacroix P. [Prevalence and prognosis of aspirin resistance in critical limb ischemia patients]. J Mal Vasc. 2016 Dec;41(6):358-364. doi: 10.1016/j.jmv.2016.08.004. Epub 2016 Oct 14. French.
  • Navarese EP, Wernly B, Lichtenauer M, Petrescu AM, Kołodziejczak M, Lauten A, Frediani L, Veulemanns V, Wanha W, Wojakowski W, Lesiak M, Ferrante G, Zeus T, Tantry U, Bliden K, Buffon A, Contegiacomo G, Jung C, Kubica J, Pestrichella V, Gurbel PA. Dual vs single antiplatelet therapy in patients with lower extremity peripheral artery disease - A meta-analysis. Int J Cardiol. 2018 Oct 15;269:292-297. doi: 10.1016/j.ijcard.2018.07.009. Epub 2018 Jul 3.
  • Soden PA, Zettervall SL, Ultee KH, Landon BE, O'Malley AJ, Goodney PP, DeMartino RR, Arya S, Schermerhorn ML; Society for Vascular Surgery Vascular Quality Initiative. Dual antiplatelet therapy is associated with prolonged survival after lower extremity revascularization. J Vasc Surg. 2016 Dec;64(6):1633-1644.e1. doi: 10.1016/j.jvs.2016.05.098. Epub 2016 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2019) 		88
Original Actual Enrollment Same as current
Actual Study Completion Date March 31, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
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 France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03953547
Other Study ID Numbers RAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Principal Investigator: Raphaël ATTAL, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date August 2018

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