Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis

NCT06807788 | Active Not Recruiting

• 1 other identifier: SDC: 5859/24/070
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory syndromes in general, and primary vasculitis specifically, present a high risk of cardiovascular involvement. Takayasu arteritis (TAK), for example, presents cardiovascular complications in up to 60% of cases. It is a systemic inflammatory disease that primarily affects large vessels, such as the aorta and its main branches. From a pathophysiological point of view, there are several causes that can lead to an exacerbated increase in cardiovascular risk in this population, including accelerated atherosclerosis, pro-inflammatory action of platelets and significant endothelial dysfunction. 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.

Conditions

Takayasu Arteritis (TAK); Vasculitis, Systemic

Keywords

Platelets; Platelet aggregation; Optical aggregometry

Outcome Measures

Primary Outcomes (1)

• Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)

  Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups

  14 days

Secondary Outcomes (11)

• Platelet aggregability by AggRAM™ arachidonic acid at baseline;

  Baseline

• Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;

  14 days

• Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day

  14 days

• Serum levels of ultrasensitive C-reactive protein (hs-CRP);

  Baseline

• Serum levels of immature platelets;

  Baseline

Other Outcomes (10)

• Subgroup Analysis- Sex

  Baseline and 14 days

• Subgroup Analysis- Age

  Baseline and 14 days

• Subgroup Analysis- BDI

  Baseline and 14 days

Study Arms (2)

Takayasu Arteritis Case Group

50 patients with Takayasu arteritis

Drug: Clopidogrel

Healthy Volunteers Control Group

50 healthy volunteers

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Clopidogrel 75 mg once a day for 14 days.

Healthy Volunteers Control Group; Takayasu Arteritis Case Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients with Takayasu arteritis 50 Healthy volunteers

You may qualify if:

• Patients with TAK, according to the ACR/EULAR 2022 classification criteria (score ≥ 5 out of a total of 20 points) \[17\]
• Age \> 18 years
• Using acetylsalicylic acid
• Agreement to sign the Free and Informed Consent Form (TCLE).

You may not qualify if:

• Previous hemorrhagic stroke
• 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

Sponsors & Collaborators

• Jose Carlos Nicolau: lead

Study Sites (1)

Heart Institute (InCor) / University of São Paulo, São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (17)

• 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.

  PMID: 36349501 BACKGROUND

• 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.

  PMID: 24640521 BACKGROUND

• 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.

  PMID: 25883536 BACKGROUND

• 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.

  PMID: 37525862 BACKGROUND

• 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.

  PMID: 18077812 BACKGROUND

• 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.

  PMID: 32774856 BACKGROUND

• 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.

  PMID: 32258788 BACKGROUND

• 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.

  PMID: 37011578 BACKGROUND

• 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.

  PMID: 29040156 BACKGROUND

• 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.

  PMID: 16439439 BACKGROUND

• 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.

  PMID: 33419482 BACKGROUND

• 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.

  PMID: 35652080 BACKGROUND

• 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.

  PMID: 33512784 BACKGROUND

• 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.

  PMID: 24097290 BACKGROUND

• 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.

  PMID: 37302927 BACKGROUND

• 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.

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  PMID: 24268007 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Takayasu Arteritis; Systemic Vasculitis

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Acute coronary Unit

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2027
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)