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CompletedNCT03953547RAPUpdated May 21, 2019

Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization

An observational study in Vascular Diseases, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
88
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Vascular Diseases

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Keywords

  • antiplatelet resistance
  • peripheral arterial revascularization
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In context

Vascular Diseases

1,036 studies on the registry are indexed under Vascular Diseases; 166 are open to participants now.

This study's enrollment of 88 is below the median of 200 across 304 observational studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 344 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and 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.

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What researchers measure

Primary outcomes

  1. Number of re-occlusion of the revascularization procedure

    Time frame: 1 year

Secondary outcomes

  1. Number of cardiovascular events

    Time frame: 1 year

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Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Île-de-France Region 75014, France
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References and documents

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. PubMed 22260716 ↗
  • 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. PubMed 19660606 ↗
  • Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni 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. No abstract available. PubMed 28886622 ↗
  • 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. PubMed 27641263 ↗
  • 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: 10.3109/09537104.2012.676220. Epub 2012 Apr 13. PubMed 22497730 ↗
  • 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. PubMed 9308744 ↗
  • 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. PubMed 19679423 ↗
  • Doly JS, Lorian E, Desormais I, Constans J, Bura Riviere 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. PubMed 27745943 ↗
  • 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 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. PubMed 30045826 ↗
  • 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. PubMed 27575814 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Mar 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2019
First posted
May 16, 2019
StartActual
Jan 1, 2018
Primary completionActual
Mar 1, 2018
CompletionActual
Mar 31, 2018
Last update
May 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03953547
Responsible party
Sponsor
First posted
May 16, 2019
Start date
Jan 1, 2018
Primary completion
Mar 1, 2018
Completion
Mar 31, 2018
Last update
May 21, 2019

Study contacts

Raphaël ATTAL, MD
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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