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

NCT06454045 | Active Not Recruiting

• 1 other identifier: SDC: 5794/24/005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Keywords

Platelets; optical aggregometry; Lower Limb disease

Outcome Measures

Primary Outcomes (1)

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

  Compare platelet aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups

  14 days

Secondary Outcomes (13)

• Platelet aggregability by AggRAM™ arachidonic acid at baseline;

  Baseline

• 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;

  14 days

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

  Baseline

• Serum levels of immature platelets;

  Baseline

Other Outcomes (10)

• Subgroup Analysis- Sex

  Baseline and 14 days

• Subgroup Analysis- Age

  Baseline and 14 days

• Subgroup Analysis- hypertension

  Baseline and 14 days

Study Arms (2)

Isolated coronary involvement (Group 1)

Patients with previous infarction and isolated coronary involvement

Drug: Clopidogrel

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

Interventions

Clopidogrel DRUG

Clopidogrel 75 mg once a day for 14 days.

Concomitant presence of Lower Extremity Peripheral Artery Disease (Group 2); Isolated coronary involvement (Group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (19)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood.

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 12, 2024
• Study Start: May 13, 2024
• Primary Completion: May 13, 2026
• Study Completion (Estimated): May 13, 2028
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)