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NCT Number: NCT06454045

Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease

After an episode of acute ischemic syndrome, patients with concomitant peripheral arterial disease have a worse short- and long-term prognosis compared to patients with isolated coronary disease, but the mechanisms responsible are poorly understood. In this population, the presence of high platelet aggregability despite the use of antiplatelet drugs is related to a greater risk of future complications, including heart attack and death from all causes.

Thus, the main objective of the present project is to evaluate the role of platelet aggregability, analyzed by optical aggregometry using the AggRAM® equipment, in patients with a history of previous acute myocardial infarction with and without the presence of peripheral arterial disease. Among the secondary objectives, it is worth analyzing platelet aggregability, in both groups, using the Plateletworks® method. This is a case-control study, with groups differentiated by the presence or absence of peripheral arterial disease, matched by sex and age.

It is expected that, in the end, relevant aspects related to platelet aggregation will be better characterized in this high cardiovascular risk population, with a likely impact on new therapeutic strategies that can positively influence the morbidity and mortality of these patients.

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This study is active but is not currently recruiting participants.

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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, 05403000, Brazil

About this study

Polyvascular involvement is frequently present in atherosclerotic disease (AD). Lower Extremity Peripheral Artery Disease (PAD) represents one of the manifestations of AD; it is estimated that around 47% of people with atherosclerotic disease have involvement in more than one vascular bed, with coronary atherosclerotic disease and lower limb AD being the most prevalent.

Initial studies suggest that platelet aggregability is increased in patients with PAD and the level of platelet aggregability is associated with the severity of PAD.However, to our knowledge, there are no studies in the literature analyzing platelet aggregability in patients with previous AMI with and without the concomitant presence of PAD, which is the proposal of this research project.

This study is an observational, case-control study, matched by sex and age. Two groups will be selected: Patients with previous infarction and isolated coronary involvement (Group 1); Patients with previous AMI and concomitant presence of PAD of the lower limbs (Group 2).

Primary objective is compare platelet aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories) between the groups. Secondary objetives includes laboratorial test of inflammation, coagulation and subgroup analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged ≥ 18 years;
  • Daily use of AAS 81-100 mg and statins;
  • History of acute myocardial infarction, proven by medical record analysis;
  • Group 2 (patients with PAD): Ankle-Brachial Index number (ABI) ≤ 0.9 in at least one of the lower limbs. In diabetic patients with ABI > 1.4, the Hallux-Brachialis Index should be performed if possible; if the patient presents a value < 0.7, they can be included;
  • Signing of the Free and Informed Consent Form.

Exclusion criteria

  • Use of adenosine-diphosphate (ADP) receptor antagonists in the last 7 days before inclusion in the study;
  • Use of Anticoagulants in the last 30 days before inclusion in the study;
  • Clopidogrel allergy;
  • Known atherosclerotic carotid disease or carotid bruit;
  • History of upper gastrointestinal bleeding in the last 12 months;
  • Pregnancy or lactation;
  • Known platelet dysfunction or platelet count <100,000/µL or >450,000/µL;
  • Known liver disease or coagulation disorder;
  • Hematocrit less than 34% or greater than 55%

Treatment and study plan

clopidogrel

Drug

Clopidogrel 75 mg once a day for 14 days.

Primary outcomes

  1. Aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)

    Time frame: 14 days

    Compare platelet aggregability 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. Mean platelet volume (MPV);

    Time frame: Baseline

    Evaluation of Mean platelet volume (MPV);

  8. Serum levels of P-Selectin ;

    Time frame: Baseline

    Evaluation of Serum levels of P-Selectin ;

  9. Serum levels of type I plasminogen activator inhibitor (PAI 1);

    Time frame: Baseline

    Evaluation of Serum levels of type I plasminogen activator inhibitor (PAI 1);

  10. Serum levels of interleukin 6;

    Time frame: Baseline

    Evaluation of Serum levels of interleukin 6;

  11. Serum levels of Interleukin 1

    Time frame: Baseline

    Evaluation of Serum levels of Interleukin 1

  12. Serum levels of cholesterol ester transfer proteins;

    Time frame: Baseline

    Evaluation of Serum levels of cholesterol ester transfer proteins;

  13. 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- hypertension

    Time frame: Baseline and 14 days

    History of arterial hypertension (presence or not);

  4. Subgroup Analysis- BDI

    Time frame: Baseline and 14 days

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

  5. Subgroup Analysis- Diabetes mellitus

    Time frame: Baseline and 14 days

    Diabetes mellitus (presence or not);

  6. Subgroup Analysis-Glomerular filtration rate

    Time frame: Baseline and 14 days

    Glomerular filtration rate (CKD EPI) (< 60ml/min/m2 or ≥ 60 ml/min/m2);

  7. Subgroup Analysis- Smoking

    Time frame: Baseline and 14 days

    Current smoking (yes or no);

  8. Subgroup Analysis- Ankle-brachial index number

    Time frame: Baseline and 14 days

    ABI 0.41-0.90 (mild/moderate) or <0.41 (Severe) or history of amputation.

  9. Subgroup Analysis- Glycated hemoglobin

    Time frame: Baseline and 14 days

    Glycated hemoglobin(more or less than 8%);

  10. Subgroup Analysis- Use of proton pump inhibitor

    Time frame: Baseline and 14 days

    Use of proton pump inhibitor (yes or no).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

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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