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

June 5, 2024 updated by: Jose Carlos Nicolau, University of Sao Paulo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403000
        • Heart Institute (InCor) / University of 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Group 1: Patients with previous infarction and isolated coronary involvement

Group 2: Patients with previous AMI and concomitant presence of Lower Extremity Peripheral Artery Disease.

Description

Inclusion Criteria:

  1. Men and women aged ≥ 18 years;
  2. Daily use of AAS 81-100 mg and statins;
  3. History of acute myocardial infarction, proven by medical record analysis;
  4. 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;
  5. Signing of the Free and Informed Consent Form.

Exclusion Criteria:

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Isolated coronary involvement (Group 1)
Patients with previous infarction and isolated coronary involvement
Drug: Clopidogrel
Clopidogrel 75 mg once a day for 14 days.
Concomitant presence of Lower Extremity Peripheral Artery Disease (Group 2)
Patients with previous AMI and concomitant presence of Lower Extremity Peripheral Artery Disease
Drug: Clopidogrel
Clopidogrel 75 mg once a day for 14 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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
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 ultrasensitive C-reactive protein (hs-CRP);
Time Frame: Baseline
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Baseline
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
Mean platelet volume (MPV);
Time Frame: Baseline
Evaluation of Mean platelet volume (MPV);
Baseline
Serum levels of P-Selectin ;
Time Frame: Baseline
Evaluation of Serum levels of P-Selectin ;
Baseline
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);
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 Serum levels of Interleukin 1
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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- hypertension
Time Frame: Baseline and 14 days
History of arterial hypertension (presence or not);
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-Glomerular filtration rate
Time Frame: Baseline and 14 days
Glomerular filtration rate (CKD EPI) (< 60ml/min/m2 or ≥ 60 ml/min/m2);
Baseline and 14 days
Subgroup Analysis- Smoking
Time Frame: Baseline and 14 days
Current smoking (yes or no);
Baseline and 14 days
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.
Baseline and 14 days
Subgroup Analysis- Glycated hemoglobin
Time Frame: Baseline and 14 days
Glycated hemoglobin(more or less than 8%);
Baseline and 14 days
Subgroup Analysis- Use of proton pump inhibitor
Time Frame: Baseline and 14 days
Use of proton pump inhibitor (yes or no).
Baseline and 14 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDC: 5794/24/005

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

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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