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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Takayasu Arteritis Case Group | 50 patients with Takayasu arteritis |
| |
| Healthy Volunteers Control Group | 50 healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Clopidogrel 75 mg once a day for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregability by AggRAM™ arachidonic acid at baseline; | Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline | Baseline |
| Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day; |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup Analysis- Sex | Sex (male/female) | Baseline and 14 days |
| Subgroup Analysis- Age | Age (≥65 years or < 65 years) | Baseline and 14 days |
Inclusion Criteria:
Exclusion Criteria:
Previous hemorrhagic stroke
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50 patients with Takayasu arteritis
50 Healthy volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor) / University of São Paulo, São Paulo | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36349501 | Background | 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. | |
| 24640521 |
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| ID | Term |
|---|---|
| D013625 | Takayasu Arteritis |
| D056647 | Systemic Vasculitis |
| ID | Term |
|---|---|
| D001015 | Aortic Arch Syndromes |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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Blood
Evaluation of 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 | Evaluation of 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); | Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP) | Baseline |
| Serum levels of immature platelets; | Evaluation of Serum levels of immature platelets | Baseline |
| Platelet count | Evaluation of Platelet count; | Baseline |
| Serum levels of P-Selectin | Evaluation of Serum levels of P-Selectin | Baseline |
| Serum levels of interleukin 6 | Evaluation of Serum levels of interleukin 6; | Baseline |
| Serum levels of Interleukin 1 | Evaluation of interleukin 1 | Baseline |
| Serum levels of cholesterol ester transfer proteins; | Evaluation of Serum levels of cholesterol ester transfer proteins; | Baseline |
| Serum levels of Lipoprotein(a) (LPa) | Evaluation of Serum levels of Lipoprotein(a) (LPa) | Baseline |
| Subgroup Analysis- BDI | Body Mass Index (<30 or ≥ 30 kg/m2); | Baseline and 14 days |
| Subgroup Analysis- Diabetes mellitus | Diabetes mellitus (presence or not); | Baseline and 14 days |
| Subgroup Analysis- Use of Statins | Use of Statins (yes or no) | Baseline and 14 days |
| Subgroup Analysis- Smoking | Current smoking (yes or no); | Baseline and 14 days |
| Subgroup Analysis- Use of Nonsteroidal Anti-inflammatory drugs | Use of Nonesteroidal ANti-inflammatory drugs ( yes or no) | Baseline and 14 days |
| Subgroup Analysis of Glomerular filtration rate (CKD-EPI) (< 60 mL/min/m2 or ≥ 60mL/min/m2) | CKD-EPI (< 60 mL/min/m2 or ≥ 60mL/min/m2) | Baseline and 14 days |
| Subgroup Analysis- Use of immunosuppressive agents | Use of immunosuppressive agents ( yes or no) | Baseline and 14 days |
| Subgroup Analysis- Use of Biological agents | Use of Biological agents ( yes or no) | Baseline and 14 days |
| 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. |
| 25883536 | 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. |
| 37525862 | 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. |
| 18077812 | 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. |
| 32774856 | 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. |
| 32258788 | 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. |
| 37011578 | 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. |
| 29040156 | 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. |
| 16439439 | 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. |
| 33419482 | 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. |
| 35652080 | 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. |
| 33512784 | 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. |
| 24097290 | 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. |
| 37302927 | 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. |
| 15777385 | 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. |
| 24268007 | Background | 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. |
| D001167 |
| Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |