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Trial record 22 of 87 for:    ASPIRIN AND thromboxane

PPARGC1β and CNTN4 Genotype Aspirin Study

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ClinicalTrials.gov Identifier: NCT02970604
Recruitment Status : Unknown
Verified November 2016 by Royal College of Surgeons, Ireland.
Recruitment status was:  Recruiting
First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

Brief Summary:

Heart attacks and strokes are common causes of death worldwide. These events occur in part, due to increased activity of platelets, which cause clotting (thrombosis) within heart and brain blood vessels.

Anti-platelet therapies (e.g. aspirin) reduce the likelihood of platelet thrombosis and therefore protect against heart attacks and strokes. However serious bleeding into the gut and brain occurs in a number of individuals prescribed aspirin. Currently, there is no reliable method for assessing the relative risks of thrombosis versus bleeding in individual patients prior to or during aspirin therapy.

We have recently discovered that individuals with a particular genetic make-up, those with genetic variants in two genes called PPARGC1β and CNTN4, demonstrate more active (sticky) platelets. We then found that these same individuals suffered a greater number of cardiovascular events. Interestingly, low dose aspirin suppressed the excessive platelet stickiness and protected against heart attacks and strokes in these patients.

In this project, we aim to confirm and extend the above findings. We hope that testing for PPARGC1β and CNTN4 genetic variants will allow us to identify which patients will benefit from low dose aspirin therapy - i.e. receive protection from heart attacks and strokes, but not suffer any bleeding complications.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PPARGC1β And CNTN4 Genotype as a Pharmacogenetic Assay of Thrombosis and Bleeding Risks - a Cross-Over Controlled Trial of Aspirin in Individuals at Increased Cardiovascular Risk.
Study Start Date : May 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Non-enteric coated Aspirin 75mg once daily for 7 days
Drug: Aspirin
Non enteric coated aspirin

No Intervention: No treatment
No treatment for 7 days



Primary Outcome Measures :
  1. Urinary Thromboxane B2/Creatinine Ratio [ Time Frame: Baseline ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subjects must be male or female outpatients.
  • Age must be greater than 18 years.
  • Subjects must be able and willing to give written informed consent, and to comply with the requirements of this study protocol.
  • Subjects must be at intermediate to high cardiovascular risk as determined by a calculated 5 year CVD risk of 5% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations)

Exclusion Criteria:

  • Age less than 18 years.
  • Previous MI, stroke, transient ischaemic attack (TIA) or known CAD.
  • Subjects who have any other significant disease or disorder (including concurrent malignancy) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
  • Known history of, or documented positive hepatitis B or C or HIV infection
  • AST or ALT ≥ 3 x ULN.
  • Creatinine clearance (CrCl) < 60 mL/min measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula.
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study, or with childbearing potential without using a medically accepted method of contraception (see notes 1-5 below)
  • Patients already taking aspirin.
  • Patients already taking anti-platelet agents (clopidogrel, ticagrelor etc), non-steroidal anti inflammatory drugs (NSAIDs), or anticoagulants (heparin, warfarin, dabigatran, etc).
  • Patients who have a known intolerance to aspirin.
  • Patients who have a contra-indication to aspirin as detailed below:

    • Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) and to any of the excipients.
    • Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.
    • Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia.
    • Patients who are suffering from gout.
    • Severe hepatic impairment.
    • Severe renal impairment.
    • Patients taking methotrexate used at doses >15mg/week.
  • History of peptic ulcer disease or upper gastrointestinal bleeding.
  • Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
  • Participants unlikely to comply well with study treatments or with the scheduled visits.
  • Scheduled for procedures requiring general anaesthesia during the study.

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): NCT02970604


Contacts
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Contact: Kirstyn James, MB 0035318093706 ext 3706 kirsjames@rcsi.ie

Locations
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Ireland
Royal College of Surgeons in Ireland Recruiting
Dublin, Ireland
Contact: Kirstyn James, MB    0035318093706 ext 3706    kirsjames@rcsi.ie   
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Investigators
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Principal Investigator: Alice Stanton, MB PhD Royal College of Surgeons in Ireland

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02970604     History of Changes
Other Study ID Numbers: RCSIMCT20152017
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aspirin
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
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics