Heart Institute (InCor) / University of São Paulo, São Paulo
São Paulo, Brazil
NCT Number: NCT06807788
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
São Paulo, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clopidogrel 75 mg once a day for 14 days.
Time frame: 14 days
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
Time frame: Baseline
Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline
Time frame: 14 days
Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;
Time frame: 14 days
Evaluation of Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day;
Time frame: Baseline
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Time frame: Baseline
Evaluation of Serum levels of immature platelets
Time frame: Baseline
Evaluation of Platelet count;
Time frame: Baseline
Evaluation of Serum levels of P-Selectin
Time frame: Baseline
Evaluation of Serum levels of interleukin 6;
Time frame: Baseline
Evaluation of interleukin 1
Time frame: Baseline
Evaluation of Serum levels of cholesterol ester transfer proteins;
Time frame: Baseline
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Time frame: Baseline and 14 days
Sex (male/female)
Time frame: Baseline and 14 days
Age (≥65 years or < 65 years)
Time frame: Baseline and 14 days
Body Mass Index (<30 or ≥ 30 kg/m2);
Time frame: Baseline and 14 days
Diabetes mellitus (presence or not);
Time frame: Baseline and 14 days
Use of Statins (yes or no)
Time frame: Baseline and 14 days
Current smoking (yes or no);
Time frame: Baseline and 14 days
Use of Nonesteroidal ANti-inflammatory drugs ( yes or no)
Time frame: Baseline and 14 days
CKD-EPI (< 60 mL/min/m2 or ≥ 60mL/min/m2)
Time frame: Baseline and 14 days
Use of immunosuppressive agents ( yes or no)
Time frame: Baseline and 14 days
Use of Biological agents ( yes or no)
Jose Carlos Nicolau
Other
Acronym: PLATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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