Heart Institute (InCor) / University of São Paulo
São Paulo, 05403000, Brazil
NCT Number: NCT06454045
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
São Paulo, 05403000, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clopidogrel 75 mg once a day for 14 days.
Time frame: 14 days
Compare platelet aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
Time frame: Baseline
Avaliation of Platelet aggregability by AggRAM™ arachidonic acid at baseline;
Time frame: 14 days
Evaluation of Platelet aggregability by AggRAM™ ADP 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;
Time frame: Baseline
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Time frame: Baseline
Evaluation of Serum levels of immature platelets;
Time frame: Baseline
Evaluation of Platelet count;
Time frame: Baseline
Evaluation of Mean platelet volume (MPV);
Time frame: Baseline
Evaluation of Serum levels of P-Selectin ;
Time frame: Baseline
Evaluation of Serum levels of type I plasminogen activator inhibitor (PAI 1);
Time frame: Baseline
Evaluation of Serum levels of interleukin 6;
Time frame: Baseline
Evaluation of Serum levels of Interleukin 1
Time frame: Baseline
Evaluation of Serum levels of cholesterol ester transfer proteins;
Time frame: Baseline
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Time frame: Baseline and 14 days
Sex (male/female)
Time frame: Baseline and 14 days
Age (≥65 years or < 65 years)
Time frame: Baseline and 14 days
History of arterial hypertension (presence or not);
Time frame: Baseline and 14 days
Body Mass Index (<30 or ≥ 30 kg/m2);
Time frame: Baseline and 14 days
Diabetes mellitus (presence or not);
Time frame: Baseline and 14 days
Glomerular filtration rate (CKD EPI) (< 60ml/min/m2 or ≥ 60 ml/min/m2);
Time frame: Baseline and 14 days
Current smoking (yes or no);
Time frame: Baseline and 14 days
ABI 0.41-0.90 (mild/moderate) or <0.41 (Severe) or history of amputation.
Time frame: Baseline and 14 days
Glycated hemoglobin(more or less than 8%);
Time frame: Baseline and 14 days
Use of proton pump inhibitor (yes or no).
University of Sao Paulo
Other
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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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