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Antiplatlet Effects of Standardized Tomato Extract in Hypertensive Subjects

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ClinicalTrials.gov Identifier: NCT03206944
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Beata Krasinska, Poznan University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension,Essential Obesity Drug: acetylsalicylic acid Drug: Tomato Fruit Extract Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiplatlet Effects of Standardized Tomato Extract in Hypertensive Subjects at High Estimated Cardiovascular Risk
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: acetylsalicylic acid
Group 1(ASA) included 33 patients who received acetylsalicylic acid at a dose of 75 mg in the morning
Other Name: Group 1 ASA

Experimental: 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.
Drug: Tomato Fruit Extract
Group 2 (STE) included 32 patients receiving standardized tomato extract (STE) (ZAAX, Sequia, Poland) at a dose of 213 mg orally in the morning
Other Name: Group 2 STE




Primary Outcome Measures :
  1. Inhibition of platelet function in response to anti-platelet therapy STE and ASA [ Time Frame: 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.


Secondary Outcome Measures :
  1. The reduction in BP after STE therapy [ Time Frame: 1 month ]
    The reduction in office BP (measured three times in standard conditions) and in 24-hour ABPM parameters



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent
  • Primary hypertension

Exclusion Criteria:

  • secondary hypertension,
  • white coat hypertension,
  • coronary artery disease,
  • myocardial infarction,
  • revascularization,
  • stroke,
  • TIA,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206944


Sponsors and Collaborators
Beata Krasinska
Investigators
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Study Director: Andrzej Tykarski, Prof Department oh Hypertension, Angiology and Internal Disease. University of Medical Sciences. Poznan,Poland

Publications of Results:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Beata Krasinska, Principal Investigator, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03206944     History of Changes
Other Study ID Numbers: 377/2015
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Beata Krasinska, Poznan University of Medical Sciences:
standardized tomato extract
anti-aggregation
high cardiovascular risk
diet supplement

Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Essential Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics