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

Active, not recruiting

Conditions

Intervention / Treatment

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

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
    • 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

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
Intervention / Treatment
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

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

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

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

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)

May 13, 2024

Primary Completion (Estimated)

May 13, 2026

Study Completion (Estimated)

May 13, 2028

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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