PPARGC1β and CNTN4 Genotype Aspirin Study

NCT02970604 | Unknown Phase 4

• 1 other identifier: RCSIMCT20152017
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Urinary Thromboxane B2/Creatinine Ratio

  Baseline

Study Arms (2)

Aspirin

EXPERIMENTAL

Non-enteric coated Aspirin 75mg once daily for 7 days

Drug: Aspirin

No treatment

NO INTERVENTION

No treatment for 7 days

Interventions

Aspirin DRUG

Non enteric coated aspirin

Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Royal College of Surgeons in Ireland

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alice Stanton, MB PhD

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstyn James, MB

CONTACT

0035318093706; kirsjames@rcsi.ie

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)