Clinical trial NCT06807788: Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis
Official title: Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Takayasu Arteritis (TAK)
Vasculitis, Systemic
Keywords: Platelets
Platelet aggregation
Optical aggregometry
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with Takayasu arteritis

50 Healthy volunteers

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.


Eligibility criteria: 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

Primary outcomes:
measure: Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
timeFrame: 14 days
Secondary outcomes:
measure: Platelet aggregability by AggRAM™ arachidonic acid at baseline;
timeFrame: Baseline
measure: Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;
timeFrame: 14 days
measure: Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day
timeFrame: 14 days
measure: Serum levels of ultrasensitive C-reactive protein (hs-CRP);
timeFrame: Baseline
measure: Serum levels of immature platelets;
timeFrame: Baseline
measure: Platelet count
timeFrame: Baseline
measure: Serum levels of P-Selectin
timeFrame: Baseline
measure: Serum levels of interleukin 6
timeFrame: Baseline
measure: Serum levels of Interleukin 1
timeFrame: Baseline
measure: Serum levels of cholesterol ester transfer proteins;
timeFrame: Baseline
measure: Serum levels of Lipoprotein(a) (LPa)
timeFrame: Baseline
Other outcomes:
measure: Subgroup Analysis- Sex
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Age
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- BDI
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Diabetes mellitus
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Use of Statins
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Smoking
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Use of Nonsteroidal Anti-inflammatory drugs
timeFrame: Baseline and 14 days
measure: Subgroup Analysis of Glomerular filtration rate (CKD-EPI) (< 60 mL/min/m2 or ≥ 60mL/min/m2)
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Use of immunosuppressive agents
timeFrame: Baseline and 14 days
measure: Subgroup Analysis- Use of Biological agents
timeFrame: Baseline and 14 days
Locations:
city: São paulo
country: Brazil
facility: Heart Institute (InCor) / University of São Paulo, São Paulo
Study officials:
References:
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