NCT03206944

Antiplatlet Effects of Standardized Tomato Extract in Hypertensive Subjects

Completed Phase 4 Last updated 2 July 2017

What this trial tests

Phase 4 trial testing acetylsalicylic acid in Hypertension,Essential in 82 participants. Completed in 1 June 2017.

Timeline

1 July 2015

Primary endpoint
1 January 2017

1 June 2017

Quick facts

Lead sponsor	Beata Krasinska
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 July 2015
Primary completion	1 January 2017
Estimated completion	1 June 2017

Drugs / interventions tested

• acetylsalicylic acid (acetylsalicylic acid) — full drug profile →
• Tomato Fruit Extract — full drug profile →

Conditions studied

• Hypertension,Essential — all drugs for Hypertension,Essential →
• Obesity — all drugs for Obesity →

Sponsor

Beata Krasinska — full company profile →

Who can join

Adults 18 to 70, any sex, with Hypertension,Essential or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effects of Eplerenone on the Circadian Blood Pressure Pattern and Left Ventricular Hypertrophy in Patients with Obstructive Sleep Apnea and Resistant Hypertension-A Randomized, Controlled Trial.
   Krasińska B, Cofta S, Szczepaniak-Chicheł L, Rzymski P, et al · · 2019 · cited 15× · PMID 31614891 · DOI 10.3390/jcm8101671
2. Standardised tomato extract as an alternative to acetylsalicylic acid in patients with primary hypertension and high cardiovascular risk - a randomised, controlled trial.
   Krasinska B, Osińska A, Osinski M, Krasinska A, et al · · 2018 · cited 12× · PMID 30002694 · DOI 10.5114/aoms.2017.69864
3. The influence of adding tomato extract and acetylsalicylic acid to hypotensive therapy on the daily blood pressure profiles of patients with arterial hypertension and high cardiovascular risk.
   Osińska AN, Begier-Krasińska B, Rzymski P, Krasińska A, et al · · 2017 · cited 5× · PMID 29354177 · DOI 10.5114/kitp.2017.72229