Antiplatlet Effects of Standardized Tomato Extract in Hypertensive Subjects at High Estimated Cardiovascular Risk
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 主要终点
- Inhibition of platelet function in response to anti-platelet therapy STE and ASA
研究概览
简要总结
The reducing the anti-aggregation properties of platelets significantly decreases the risk of myocardial infarction and the total number of cardiovascular events. In patients who have cardiovascular disease, anti-platelet therapy reduces the risk of serious vascular events. Side effects, such as bleeding, are relatively small so the benefits of anti-platelet therapy in secondary prevention exceed the risk of these side effects. According to guidelines for the treatment of arterial hypertension, PTNT 2015, patients with arterial hypertension (HA) that have a 20% or higher risk for cardiovascular events in the next 10 years, should have ASA included in their treatment to reduce this risk. It has been proved that the use of acetylsalicylic acid in secondary prevention reduces the risk of major cardiovascular events, while the benefits of ASA in primary prevention have recently been debated. The benefits of using ASA in primary prevention should always be confronted with the risk of hemorrhagic complications of this therapy According to 2016 European Guidelines on cardiovascular disease (CVD) prevention in clinical practice, anti-platelet therapy is not recommended in individuals who do not suffer from CVD, due to the increased risk of major bleeding. It is important to look for alternative anti-platelet therapy for people with cardiovascular risk factors. Standardized tomato extract (STE) does not cause side effects and may have multiple beneficial effects on total cardiovascular risk, primarily by inhibiting platelet aggregation. Since its discovery in 1999, several studies and human trials with STE have been carried out. During the last 50 years, tomato (Lycopersicon esculentum) has become a highly consumed food. The benefits of inhibiting platelet activity through diet are currently difficult to determine due to the lack of clear and comprehensive scientific data. It is difficult to specify the over activity of the plaques or their proper activity. However, there are data available that indicate the benefits of a diet containing diminishing activity of platelets (Mediterranean diet) and lowering cardiovascular risk.The investigators want to conduct a comparison of the less common STE with clinically recognized ASA. The aim of the study was to compare the anti-platelet effect of STE and ASA in hypertensive patients with high cardiovascular risk.The study highlights that STE may be an alternative, food-based strategy to control the platelets reactivity.
详细描述
Study design The study involved 82 high-risk hypertensive patients (44 men and 38 women), aged 28-74years, conducted between July 2015 and February 2017 in the Department of Hypertension at the University of Medical Sciences in Poznan. Seventeen patients reported resignation during the study. The permission no. 377/15 to conduct the study was published by the Ethics Committee at the Poznan University of Medical Sciences. All the patients gave informed consent for participation in the study. Patients with primary hypertension and high cardiovascular risk were randomly assigned to one of two groups. Group 1(ASA) included 33 patients who received acetylsalicylic acid at a dose of 75 mg in the morning. Group 2 (STE) included 32 patients receiving standardized tomato extract (STE) (ZAAX, Sequia, Poland) at a dose of 213 mg orally in the morning.
The patients had two visits within 4 weeks according to the scheme:
Visit 1: During the first visit, patients were qualified for the study. The patients with previously diagnosed hypertension were referred from an outpatient clinic, to the hospital ward. After admission, the patients with high cardiovascular risk were isolated and written consents were obtained.
On the basis of stage of hypertension, presence of risk factors and subclinical organ damage, diabetes coexistence, cardiovascular complications and chronic kidney disease the cardiovascular risk was estimated. Each patient with one or two risk factors and a blood pressure (BP) > 180/110 mmHg or three or more risk factors, and a BP >160/100 mmHg or with the presence of organ damage and BP >140/90 mmHg were classified as a high risk Group.There have been no changes in the concomitant treatment (lipid-lowering, anti-hypertensive and antidiabetic) during the study.
Numerous laboratory tests and imaging, such as aldosterone and ARO levels, both before and after tilting, creatinine, urea, GFR, sodium, potassium, pro BNP, TSH, FT3, FT4, and a 24-hour collection for electrolytes were collected. Abdominal ultrasound examinations, computed tomography of the abdomen, and Doppler ultrasound of the renal arteries were performed to exclude secondary causes of hypertension. Clinical BP measurements were performed three times, as well as, ambulatory blood pressure monitoring (ABPM) and echocardiography was conducted. Whole blood samples were taken and baseline platelet aggregation was determined using the VerifyNow analyzer from Accumetrics. In Group 1, two whole blood samples for VerifyNow Aspirin test were assayed. In Group 2, four whole blood samples for VerifyNow Aspirin and P2Y12 tests were assayed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •Primary hypertension
排除标准
- •secondary hypertension,
- •white coat hypertension,
- •coronary artery disease,
- •myocardial infarction,
- •revascularization,
- •lower limb atherosclerosis,
- •congestive heart failure NYHA III-IV,
- •chronic kidney disease (GFR 30 ml/min),
- •addiction to alcohol and psychotropic substances,
- •active cancer,
- •congenital or acquired haemostatic disorder,
- •use of ASA, STE, or other antiplatelet agents within the last 14 days.
- •additional ex-clusion criteria for Group 2 were hypersensitivity to acetylsalicylic acid and ac-tive gastric or duodenal ulcers.
研究组 & 干预措施
Group 1 ASA
Group 1(ASA) included 33 patients who received acetylsalicylic acid at a dose of 75 mg orally once a day in the morning.
干预措施: acetylsalicylic acid (Drug)
Group 2 STE
Group 2 (STE) included 32 patients receiving tomato fruit extract (STE) (ZAAX, Sequia, Poland) at a dose of 213 mg orally once a day in the morning.
干预措施: Tomato Fruit Extract (Drug)
结局指标
主要结局
Inhibition of platelet function in response to anti-platelet therapy STE and ASA
时间窗: 1 month
The platelet inhibition after STE and ASA therapy (VerifyNow Aspirin for ASA and STE Groups and VerifyNow P2Y12 for STE Group only) The platelet reactivity measurements will be performed using the VerifyNow Tests (Accumetrics Inc., USA) method.
次要结局
- The reduction in BP after STE therapy(1 month)
研究者
Beata Krasinska
Principal Investigator
Poznan University of Medical Sciences