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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	28 November 2016
Main ID:	NCT02970604
Date of registration:	18/11/2016
Prospective Registration:	No
Primary sponsor:	Royal College of Surgeons, Ireland
Public title:	PPARGC1ß and CNTN4 Genotype Aspirin Study
Scientific title:	PPARGC1ß 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.
Date of first enrolment:	May 2016
Target sample size:	160
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02970604
Study type:	Interventional
Study design:	Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Phase:	Phase 4

Countries of recruitment
Ireland

Contacts

Name:	Kirstyn James, MB
Address:
Telephone:	0035318093706
Email:	kirsjames@rcsi.ie
Affiliation:

Name:	Alice Stanton, MB PhD
Address:
Telephone:
Email:
Affiliation:	Royal College of Surgeons in Ireland

Name:	Kirstyn James, MB
Address:
Telephone:	0035318093706
Email:	kirsjames@rcsi.ie
Affiliation:

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Intervention(s)

Drug: Aspirin

Primary Outcome(s)

Urinary Thromboxane B2/Creatinine Ratio [Time Frame: Baseline]

Secondary Outcome(s)

Secondary ID(s)

RCSIMCT20152017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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