An observational study in Takayasu Arteritis (TAK) and Vasculitis, Systemic, sponsored by Jose Carlos Nicolau. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Jose Carlos Nicolau · Observational
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.
78 studies on the registry are indexed under Takayasu Arteritis; 32 are open to participants now.
This study's planned enrollment of 100 is below the median of 224 across 41 observational studies indexed under Takayasu Arteritis.
Browse Takayasu Arteritis studies →This is the only study on the registry with Jose Carlos Nicolau as lead sponsor.
Counted across the registry records on this site, refreshed daily.
50 patients with Takayasu arteritis
50 Healthy volunteers
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.
Exclusion Criteria:
Previous hemorrhagic stroke
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 patients with Takayasu arteritis
Drug: Clopidogrel
50 healthy volunteers
Drug: Clopidogrel
Clopidogrel 75 mg once a day for 14 days.
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
Time frame: 14 days
Platelet aggregability by AggRAM™ arachidonic acid at baseline;
Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline
Time frame: 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;
Time frame: 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;
Time frame: 14 days
Serum levels of ultrasensitive C-reactive protein (hs-CRP);
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Time frame: Baseline
Serum levels of immature platelets;
Evaluation of Serum levels of immature platelets
Time frame: Baseline
Platelet count
Evaluation of Platelet count;
Time frame: Baseline
Serum levels of P-Selectin
Evaluation of Serum levels of P-Selectin
Time frame: Baseline
Serum levels of interleukin 6
Evaluation of Serum levels of interleukin 6;
Time frame: Baseline
Serum levels of Interleukin 1
Evaluation of interleukin 1
Time frame: Baseline
Serum levels of cholesterol ester transfer proteins;
Evaluation of Serum levels of cholesterol ester transfer proteins;
Time frame: Baseline
Serum levels of Lipoprotein(a) (LPa)
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Time frame: Baseline
Subgroup Analysis- Sex
Sex (male/female)
Time frame: Baseline and 14 days
Subgroup Analysis- Age
Age (≥65 years or \< 65 years)
Time frame: Baseline and 14 days
Subgroup Analysis- BDI
Body Mass Index (\<30 or ≥ 30 kg/m2);
Time frame: Baseline and 14 days
Subgroup Analysis- Diabetes mellitus
Diabetes mellitus (presence or not);
Time frame: Baseline and 14 days
Subgroup Analysis- Use of Statins
Use of Statins (yes or no)
Time frame: Baseline and 14 days
Subgroup Analysis- Smoking
Current smoking (yes or no);
Time frame: Baseline and 14 days
Subgroup Analysis- Use of Nonsteroidal Anti-inflammatory drugs
Use of Nonesteroidal ANti-inflammatory drugs ( yes or no)
Time frame: 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)
Time frame: Baseline and 14 days
Subgroup Analysis- Use of immunosuppressive agents
Use of immunosuppressive agents ( yes or no)
Time frame: Baseline and 14 days
Subgroup Analysis- Use of Biological agents
Use of Biological agents ( yes or no)
Time frame: Baseline and 14 days
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.
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This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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