Takayasu Arteritis (TAK), Vasculitis, Systemic
Conditions
Keywords
Platelets, Platelet aggregation, Optical aggregometry
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.
Interventions
DRUGClopidogrel
Clopidogrel 75 mg once a day for 14 days.
Sponsors
Jose Carlos Nicolau
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories) | 14 days | Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day; | 14 days | Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day; |
| Platelet aggregability by AggRAM™ arachidonic acid at baseline; | Baseline | Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline |
| Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day | 14 days | Evaluation of Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day; |
| Serum levels of ultrasensitive C-reactive protein (hs-CRP); | Baseline | Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP) |
| Serum levels of immature platelets; | Baseline | Evaluation of Serum levels of immature platelets |
| Platelet count | Baseline | Evaluation of Platelet count; |
| Serum levels of P-Selectin | Baseline | Evaluation of Serum levels of P-Selectin |
| Serum levels of interleukin 6 | Baseline | Evaluation of Serum levels of interleukin 6; |
| Serum levels of Interleukin 1 | Baseline | Evaluation of interleukin 1 |
| Serum levels of cholesterol ester transfer proteins; | Baseline | Evaluation of Serum levels of cholesterol ester transfer proteins; |
| Serum levels of Lipoprotein(a) (LPa) | Baseline | Evaluation of Serum levels of Lipoprotein(a) (LPa) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis- BDI | Baseline and 14 days | Body Mass Index (\<30 or ≥ 30 kg/m2); |
| Subgroup Analysis- Diabetes mellitus | Baseline and 14 days | Diabetes mellitus (presence or not); |
| Subgroup Analysis- Use of Statins | Baseline and 14 days | Use of Statins (yes or no) |
| Subgroup Analysis- Smoking | Baseline and 14 days | Current smoking (yes or no); |
| Subgroup Analysis- Use of Nonsteroidal Anti-inflammatory drugs | Baseline and 14 days | Use of Nonesteroidal ANti-inflammatory drugs ( yes or no) |
| Subgroup Analysis of Glomerular filtration rate (CKD-EPI) (< 60 mL/min/m2 or ≥ 60mL/min/m2) | Baseline and 14 days | CKD-EPI (\< 60 mL/min/m2 or ≥ 60mL/min/m2) |
| Subgroup Analysis- Use of immunosuppressive agents | Baseline and 14 days | Use of immunosuppressive agents ( yes or no) |
| Subgroup Analysis- Use of Biological agents | Baseline and 14 days | Use of Biological agents ( yes or no) |
| Subgroup Analysis- Age | Baseline and 14 days | Age (≥65 years or \< 65 years) |
| Subgroup Analysis- Sex | Baseline and 14 days | Sex (male/female) |
Countries
Brazil
Outcome results
None listed