Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization

Vascular Diseases Clinical Trial

— RAP  

Official title:

Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953547
• Other study ID #: RAP
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 31, 2018

Study information

• Verified date: August 2018
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 31, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Diseases

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. Wor — View Citation

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. — View Citation

Mazur P, Frolow M, Nizankowski 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: 10.3 — View Citation

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 arteri — View Citation

Navarese EP, Wernly B, Lichtenauer M, Petrescu AM, Kolodziejczak 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 — View Citation

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 — View Citation

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 — View Citation

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 r — View Citation

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 Practic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of re-occlusion of the revascularization procedure		1 year
Secondary	Number of cardiovascular events		1 year