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

January 29, 2025 updated by: Jose Carlos Nicolau

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São paulo, Brazil
        • Heart Institute (InCor) / University of São Paulo, São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

50 patients with Takayasu arteritis

50 Healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Takayasu Arteritis Case Group
50 patients with Takayasu arteritis
Drug: Clopidogrel
Clopidogrel 75 mg once a day for 14 days.
Healthy Volunteers Control Group
50 healthy volunteers
Drug: Clopidogrel
Clopidogrel 75 mg once a day for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
Time Frame: 14 days
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;
Time Frame: 14 days
Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day;
14 days
Serum levels of ultrasensitive C-reactive protein (hs-CRP);
Time Frame: Baseline
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Baseline
Serum levels of cholesterol ester transfer proteins;
Time Frame: Baseline
Evaluation of Serum levels of cholesterol ester transfer proteins;
Baseline
Serum levels of Lipoprotein(a) (LPa)
Time Frame: Baseline
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Baseline
Platelet aggregability by AggRAM™ arachidonic acid at baseline;
Time Frame: Baseline
Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline
Baseline
Platelet aggregability by Plateletworks-ADP at baseline and 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;
14 days
Serum levels of immature platelets;
Time Frame: Baseline
Evaluation of Serum levels of immature platelets
Baseline
Platelet count
Time Frame: Baseline
Evaluation of Platelet count;
Baseline
Serum levels of P-Selectin
Time Frame: Baseline
Evaluation of Serum levels of P-Selectin
Baseline
Serum levels of interleukin 6
Time Frame: Baseline
Evaluation of Serum levels of interleukin 6;
Baseline
Serum levels of Interleukin 1
Time Frame: Baseline
Evaluation of interleukin 1
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup Analysis- Sex
Time Frame: Baseline and 14 days
Sex (male/female)
Baseline and 14 days
Subgroup Analysis- Age
Time Frame: Baseline and 14 days
Age (≥65 years or < 65 years)
Baseline and 14 days
Subgroup Analysis- BDI
Time Frame: Baseline and 14 days
Body Mass Index (<30 or ≥ 30 kg/m2);
Baseline and 14 days
Subgroup Analysis- Diabetes mellitus
Time Frame: Baseline and 14 days
Diabetes mellitus (presence or not);
Baseline and 14 days
Subgroup Analysis- Smoking
Time Frame: Baseline and 14 days
Current smoking (yes or no);
Baseline and 14 days
Subgroup Analysis- Use of Statins
Time Frame: Baseline and 14 days
Use of Statins (yes or no)
Baseline and 14 days
Subgroup Analysis- Use of Nonsteroidal Anti-inflammatory drugs
Time Frame: Baseline and 14 days
Use of Nonesteroidal ANti-inflammatory drugs ( yes or no)
Baseline and 14 days
Subgroup Analysis of Glomerular filtration rate (CKD-EPI) (< 60 mL/min/m2 or ≥ 60mL/min/m2)
Time Frame: Baseline and 14 days
CKD-EPI (< 60 mL/min/m2 or ≥ 60mL/min/m2)
Baseline and 14 days
Subgroup Analysis- Use of immunosuppressive agents
Time Frame: Baseline and 14 days
Use of immunosuppressive agents ( yes or no)
Baseline and 14 days
Subgroup Analysis- Use of Biological agents
Time Frame: Baseline and 14 days
Use of Biological agents ( yes or no)
Baseline and 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Carlos Nicolau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

October 14, 2027

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC: 5859/24/070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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