Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis
NCT ID: NCT06807788
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2024-10-14
2027-10-14
Brief Summary
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In this context, the present case-control study intends to include 100 individuals (50 with TAK - case group, and 50 healthy volunteers - control group), matched by age and sex in a 1:1 ratio. The main objective of the study is to compare platelet aggregability in patients with TAK against healthy volunteers using the AggRAM® test. Among its secondary objectives is the analysis of platelet aggregability by other methods (Plateletworks, Chronolog, and PPAnalysis).
The study aims to significantly contribute to a better understanding of the potential influence of TAK on platelet aggregation and the response to antiplatelet agents, thereby contributing to a better understanding of the disease, with evident prognostic and therapeutic implications.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Takayasu Arteritis Case Group
50 patients with Takayasu arteritis
Clopidogrel
Clopidogrel 75 mg once a day for 14 days.
Healthy Volunteers Control Group
50 healthy volunteers
Clopidogrel
Clopidogrel 75 mg once a day for 14 days.
Interventions
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Clopidogrel
Clopidogrel 75 mg once a day for 14 days.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Using acetylsalicylic acid
* Agreement to sign the Free and Informed Consent Form (TCLE).
Exclusion Criteria
* Use of another antiplatelet agent other than acetylsalicylic acid
* Active infection or current use of systemic antimicrobial therapy
* Known platelet dysfunction or platelets \<150,000/µL or \>450,000/µL
* Severe illness with life expectancy ≤12 months
* Known liver disease or coagulation disorder
* Abuse of illicit drugs or alcohol
* Dementia, psychiatric condition or any condition that, in the researcher's opinion, prevents participation and follow-up in the protocol
18 Years
ALL
Yes
Sponsors
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Jose Carlos Nicolau
OTHER
Responsible Party
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Jose Carlos Nicolau
Director of the Acute coronary Unit
Locations
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Heart Institute (InCor) / University of São Paulo, São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Grayson PC, Ponte C, Suppiah R, Robson JC, Gribbons KB, Judge A, Craven A, Khalid S, Hutchings A, Danda D, Luqmani RA, Watts RA, Merkel PA; DCVAS Study Group. 2022 American College of Rheumatology/EULAR Classification Criteria for Takayasu Arteritis. Arthritis Rheumatol. 2022 Dec;74(12):1872-1880. doi: 10.1002/art.42324. Epub 2022 Nov 8.
Alibaz-Oner F, Yurdakul S, Aytekin S, Direskeneli H. Impaired endothelial function in patients with Takayasu's arteritis. Acta Cardiol. 2014 Feb;69(1):45-9. doi: 10.1080/ac.69.1.3011344.
Emmi G, Silvestri E, Squatrito D, Amedei A, Niccolai E, D'Elios MM, Della Bella C, Grassi A, Becatti M, Fiorillo C, Emmi L, Vaglio A, Prisco D. Thrombosis in vasculitis: from pathogenesis to treatment. Thromb J. 2015 Apr 16;13:15. doi: 10.1186/s12959-015-0047-z. eCollection 2015.
Bhandari S, Butt SRR, Ishfaq A, Attaallah MH, Ekhator C, Halappa Nagaraj R, Mulmi A, Kamran M, Karski A, Vargas KI, Lazarevic S, Zaman MU, Lakshmipriya Vetrivendan G, Shahzed SMI, Das A, Yadav V, Bellegarde SB, Ullah A. Pathophysiology, Diagnosis, and Management of Takayasu Arteritis: A Review of Current Advances. Cureus. 2023 Jul 29;15(7):e42667. doi: 10.7759/cureus.42667. eCollection 2023 Jul.
Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
Chen Y, Zhong H, Zhao Y, Luo X, Gao W. Role of platelet biomarkers in inflammatory response. Biomark Res. 2020 Aug 2;8:28. doi: 10.1186/s40364-020-00207-2. eCollection 2020.
Sonmez O, Sonmez M. Role of platelets in immune system and inflammation. Porto Biomed J. 2017 Nov-Dec;2(6):311-314. doi: 10.1016/j.pbj.2017.05.005. Epub 2017 Oct 12.
Ucar AK, Ozdede A, Kayadibi Y, Adaletli I, Melikoglu M, Fresko I, Seyahi E. Increased arterial stiffness and accelerated atherosclerosis in Takayasu arteritis. Semin Arthritis Rheum. 2023 Jun;60:152199. doi: 10.1016/j.semarthrit.2023.152199. Epub 2023 Mar 29.
Argyropoulou OD, Protogerou AD, Sfikakis PP. Accelerated atheromatosis and arteriosclerosis in primary systemic vasculitides: current evidence and future perspectives. Curr Opin Rheumatol. 2018 Jan;30(1):36-43. doi: 10.1097/BOR.0000000000000453.
Seyahi E, Ugurlu S, Cumali R, Balci H, Seyahi N, Yurdakul S, Yazici H. Atherosclerosis in Takayasu arteritis. Ann Rheum Dis. 2006 Sep;65(9):1202-7. doi: 10.1136/ard.2005.047498. Epub 2006 Jan 26.
Dos Santos AM, Misse RG, Borges IBP, Gualano B, de Souza AWS, Takayama L, Pereira RMR, Shinjo SK. Increased modifiable cardiovascular risk factors in patients with Takayasu arteritis: a multicenter cross-sectional study. Adv Rheumatol. 2021 Jan 8;61(1):1. doi: 10.1186/s42358-020-00157-1.
Cicco S, Desantis V, Vacca A, Cazzato G, Solimando AG, Cirulli A, Noviello S, Susca C, Prete M, Brosolo G, Catena C, Lamanuzzi A, Saltarella I, Frassanito MA, Cimmino A, Ingravallo G, Resta L, Ria R, Montagnani M. Cardiovascular Risk in Patients With Takayasu Arteritis Directly Correlates With Diastolic Dysfunction and Inflammatory Cell Infiltration in the Vessel Wall: A Clinical, ex vivo and in vitro Analysis. Front Med (Lausanne). 2022 May 16;9:863150. doi: 10.3389/fmed.2022.863150. eCollection 2022.
Dua AB, Kalot MA, Husainat NM, Byram K, Springer JM, James KE, Chang Lin Y, Turgunbaev M, Villa-Forte A, Abril A, Langford C, Maz M, Chung SA, Mustafa RA. Takayasu Arteritis: a Systematic Review and Meta-Analysis of Test Accuracy and Benefits and Harms of Common Treatments. ACR Open Rheumatol. 2021 Feb;3(2):80-90. doi: 10.1002/acr2.11186. Epub 2021 Jan 29.
Keser G, Direskeneli H, Aksu K. Management of Takayasu arteritis: a systematic review. Rheumatology (Oxford). 2014 May;53(5):793-801. doi: 10.1093/rheumatology/ket320. Epub 2013 Oct 4.
Misra DP, Sharma A, Karpouzas GA, Kitas GD. Cardiovascular risk in vasculitis. Best Pract Res Clin Rheumatol. 2023 Mar;37(1):101831. doi: 10.1016/j.berh.2023.101831. Epub 2023 Jun 9.
Mwipatayi BP, Jeffery PC, Beningfield SJ, Matley PJ, Naidoo NG, Kalla AA, Kahn D. Takayasu arteritis: clinical features and management: report of 272 cases. ANZ J Surg. 2005 Mar;75(3):110-7. doi: 10.1111/j.1445-2197.2005.03312.x.
Miloslavsky E, Unizony S. The heart in vasculitis. Rheum Dis Clin North Am. 2014 Feb;40(1):11-26. doi: 10.1016/j.rdc.2013.10.006.
Other Identifiers
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SDC: 5859/24/070
Identifier Type: -
Identifier Source: org_study_id
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