| Registry | NCT06807788, acronym PLATE |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Jose Carlos Nicolau (Other) |
| Conditions | Takayasu Arteritis (TAK), Vasculitis, Systemic |
| Interventions | Clopidogrel (Drug) |
| Dates | start 2024-10-14, primary completion 2026-10-14 (estimated), completion 2027-10-14 (estimated), first posted 2025-02-04, last updated 2025-02-04 |
| Locations | 1 site in Brazil |
Related Papers Related Patents Related Grants Related Experts
All trials for Takayasu Arteritis (TAK) All trials for Vasculitis, Systemic All trials of Clopidogrel
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Takayasu Arteritis Case Group | Drug: Clopidogrel | 50 patients with Takayasu arteritis | |
| Healthy Volunteers Control Group | Drug: Clopidogrel | 50 healthy volunteers |
Sex: All, ages: 18 Years to any, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Heart Institute (InCor) / University of São Paulo, São Paulo | São Paulo, São Paulo | Brazil |