Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis (PLATE)

Jose Carlos Nicolau

Status

Active, not recruiting

Conditions

Takayasu Arteritis (TAK)

Vasculitis, Systemic

Treatments

Drug: Clopidogrel

Study type

Observational

Funder types

Other

Identifiers

NCT06807788

SDC: 5859/24/070

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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