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Active, Not Recruiting

NCT Number: NCT06807788

Evaluation of Platelet Aggregability in Patients with Takayasu's Arteritis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Institute (InCor) / University of São Paulo, São Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Clopidogrel 75 mg once a day for 14 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. Platelet aggregability by AggRAM™ arachidonic acid at baseline;

    Time frame: Baseline

    Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline

  2. 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;

  3. 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;

  4. Serum levels of ultrasensitive C-reactive protein (hs-CRP);

    Time frame: Baseline

    Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)

  5. Serum levels of immature platelets;

    Time frame: Baseline

    Evaluation of Serum levels of immature platelets

  6. Platelet count

    Time frame: Baseline

    Evaluation of Platelet count;

  7. Serum levels of P-Selectin

    Time frame: Baseline

    Evaluation of Serum levels of P-Selectin

  8. Serum levels of interleukin 6

    Time frame: Baseline

    Evaluation of Serum levels of interleukin 6;

  9. Serum levels of Interleukin 1

    Time frame: Baseline

    Evaluation of interleukin 1

  10. Serum levels of cholesterol ester transfer proteins;

    Time frame: Baseline

    Evaluation of Serum levels of cholesterol ester transfer proteins;

  11. Serum levels of Lipoprotein(a) (LPa)

    Time frame: Baseline

    Evaluation of Serum levels of Lipoprotein(a) (LPa)

Other outcomes

  1. Subgroup Analysis- Sex

    Time frame: Baseline and 14 days

    Sex (male/female)

  2. Subgroup Analysis- Age

    Time frame: Baseline and 14 days

    Age (≥65 years or < 65 years)

  3. Subgroup Analysis- BDI

    Time frame: Baseline and 14 days

    Body Mass Index (<30 or ≥ 30 kg/m2);

  4. Subgroup Analysis- Diabetes mellitus

    Time frame: Baseline and 14 days

    Diabetes mellitus (presence or not);

  5. Subgroup Analysis- Use of Statins

    Time frame: Baseline and 14 days

    Use of Statins (yes or no)

  6. Subgroup Analysis- Smoking

    Time frame: Baseline and 14 days

    Current smoking (yes or no);

  7. Subgroup Analysis- Use of Nonsteroidal Anti-inflammatory drugs

    Time frame: Baseline and 14 days

    Use of Nonesteroidal ANti-inflammatory drugs ( yes or no)

  8. 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)

  9. Subgroup Analysis- Use of immunosuppressive agents

    Time frame: Baseline and 14 days

    Use of immunosuppressive agents ( yes or no)

  10. Subgroup Analysis- Use of Biological agents

    Time frame: Baseline and 14 days

    Use of Biological agents ( yes or no)

Sponsors and collaborators

Lead sponsor

Jose Carlos Nicolau

Other

Registry information

Acronym: PLATE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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