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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

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Urinary Thromboxane B2/Creatinine Ratio [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PPARGC1β and CNTN4 Genotype Aspirin Study
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE Drug: Aspirin
Non enteric coated aspirin
Study Arms  ICMJE
  • Experimental: Aspirin
    Non-enteric coated Aspirin 75mg once daily for 7 days
    Intervention: Drug: Aspirin
  • No Intervention: No treatment
    No treatment for 7 days
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970604
Other Study ID Numbers  ICMJE RCSIMCT20152017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Royal College of Surgeons, Ireland
Study Sponsor  ICMJE Royal College of Surgeons, Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alice Stanton, MB PhD Royal College of Surgeons in Ireland
PRS Account Royal College of Surgeons, Ireland
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP