Takayasu Arteritis (TAK)PLATENCT06807788
Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis
An observational study of Takayasu Arteritis (TAK) and Vasculitis, Systemic, run by Jose Carlos Nicolau at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Takayasu Arteritis (TAK), Vasculitis, Systemic
- What is being tested?
- Clopidogrel
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Oct 2024to 14 Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with Takayasu arteritis 50 Healthy volunteers
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) / University of São Paulo, São Paulo
São Paulo, São Paulo
About this study
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
- Being tested
- Clopidogrel
- Keywords
- Platelets, Platelet aggregation, Optical aggregometry
- Medical subject headings
- Takayasu Arteritis, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Clopidogrel 75 mg once a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Takayasu Arteritis Case Group | 50 patients with Takayasu arteritis Receives: Drug: Clopidogrel | |
| Healthy Volunteers Control Group | 50 healthy volunteers Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
Measured: 14 days
Secondary outcomes (11)
Platelet aggregability by AggRAM™ arachidonic acid at baseline;
Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline
Measured: Baseline
Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;
Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;
Measured: 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;
Measured: 14 days
Serum levels of ultrasensitive C-reactive protein (hs-CRP);
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Measured: Baseline
Serum levels of immature platelets;
Evaluation of Serum levels of immature platelets
Measured: Baseline
Platelet count
Evaluation of Platelet count;
Measured: Baseline
Serum levels of P-Selectin
Evaluation of Serum levels of P-Selectin
Measured: Baseline
Serum levels of interleukin 6
Evaluation of Serum levels of interleukin 6;
Measured: Baseline
Serum levels of Interleukin 1
Evaluation of interleukin 1
Measured: Baseline
Serum levels of cholesterol ester transfer proteins;
Evaluation of Serum levels of cholesterol ester transfer proteins;
Measured: Baseline
Serum levels of Lipoprotein(a) (LPa)
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start14 Oct 2024
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Takayasu Arteritis (TAK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Carlos Nicolau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Carlos Nicolau, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807788
- Sponsor's protocol ID
- SDC: 5859/24/070
- Acronym
- PLATE
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36349501Alibaz-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.
PubMed 24640521Emmi 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.
PubMed 25883536Bhandari 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.
PubMed 37525862Davi 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.
PubMed 18077812Chen 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.
PubMed 32774856Sonmez 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.
PubMed 32258788Ucar 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.
PubMed 37011578Argyropoulou 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.
PubMed 29040156Seyahi 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.
PubMed 16439439Dos 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.
PubMed 33419482Cicco 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.
PubMed 35652080Dua 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.
PubMed 33512784Keser 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.
PubMed 24097290Misra 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.
PubMed 37302927