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Clinical Trials in Brazil / NCT06454045
Active, not recruiting Observational

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

NCT06454045 · tracked via the Priya Life Science Brazil tracker
Sponsor
University of Sao Paulo
Phase
Observational
Started
2024-05-13
Last updated
2024-06-12

Condition(s) studied

Coronary Artery DiseasePeripheral Arterial Disease

Investigational drug(s) / intervention(s)

Clopidogrel →

Clopidogrel: Clopidogrel 75 mg once a day for 14 days.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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%

Primary outcome measure(s)

Trial sites (1)

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

On this site

📄 Plavix (clopidogrel) drug profile →

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Other trials for the same condition

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Photobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting. Starting soon
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients Active, not recruiting
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06454045 on ClinicalTrials.gov ↗ ← All trials in Brazil