Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Use of adenosine-diphosphate (ADP) receptor antagonists in the last 7 days before inclusion in the study;
- •Use of Anticoagulants in the last 30 days before inclusion in the study;
- •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%
研究组 & 干预措施
Isolated coronary involvement (Group 1)
Patients with previous infarction and isolated coronary involvement
干预措施: Clopidogrel (Drug)
Concomitant presence of Lower Extremity Peripheral Artery Disease (Group 2)
Patients with previous AMI and concomitant presence of Lower Extremity Peripheral Artery Disease
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
时间窗: 14 days
Compare platelet aggregability analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
次要结局
- Serum levels of Interleukin 1(Baseline)
- Platelet count;(Baseline)
- Serum levels of Lipoprotein(a) (LPa)(Baseline)
- Serum levels of interleukin 6;(Baseline)
- Serum levels of immature platelets;(Baseline)
- Serum levels of P-Selectin ;(Baseline)
- Platelet aggregability by AggRAM™ arachidonic acid at baseline;(Baseline)
- Serum levels of ultrasensitive C-reactive protein (hs-CRP);(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)
- Mean platelet volume (MPV);(Baseline)
- Serum levels of type I plasminogen activator inhibitor (PAI 1);(Baseline)
- Serum levels of cholesterol ester transfer proteins;(Baseline)
研究者
Jose Carlos Nicolau
Professor
University of Sao Paulo