Clinical Trials

Coronary Artery Disease Risk

Coronary artery disease causes an inadequate supply of blood to the heart muscle. It is also referred to as coronary heart disease.


REDUCE-IT Outcomes Trial

This research study will evaluate the effectiveness of an investigational medication (prescription-grade omega-3 fatty acid) in reducing major cardiovascular events in an at-risk patient population.

All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. The study will require approximately 8,000 patients and take approximately 6 years for completion.

        RECRUITMENT COMPLETED.



CANTOS

A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP.

This study is being carried out to see if a drug called canakinumab given as sub-cutaneous injections, is beneficial in reducing cardiovascular events in patients who have had a heart attack and demonstrate ongoing increased inflammation.

        RECRUITMENT COMPLETED.



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THEMIS Study

This study is being carried out to valuate the effect of ticagrelor compared to placebo in reducing cardiovascular events such as myocardial infarction (MI) (heart attack), ischemic stroke, and cardiovascular (CV) related death, in patients with Type 2 Diabetes.

Ages Eligible for Study :   50 Years and older
Genders Eligible for Study :   Both
Accepts Healthy Volunteers    :   No

Inclusion Criteria

Men or women >50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication for at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

This study has been approved by Bellberry Human Research Ethics Committee.

        RECRUITMENT COMPLETED.



Strength Study

A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH).

The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with elevated triglyceride levels and high risk for Cardiovascular Disease to be randomized 1:1 to either corn oil + statin or Epanova + statin, administered as an oral dose of 4g once daily, for approximately 3-5 years as determined when the number of Major Adverse Clinical Events outcomes is reached.

Ages Eligible for Study :   18 Years and older
Genders Eligible for Study :   Both
Accepts Healthy Volunteers    :   No

        RECRUITMENT COMPLETED.



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DALGenE study

Effect of Dalcetrapib vs Placebo on Cardiovascular Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (dal-GenE).

Ages Eligible for Study :   45 Years and older
Genders Eligible for Study :   Both
Accepts Healthy Volunteers    :   No

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Subjects will visit the clinic 1 month after randomization and at regular biannual intervals thereafter.

This study has been approved by Bellberry Human Research Ethics Committee.

        OPEN TO RECRUITMENT.



Observational

An observational study observes the effect of a drug or device, or an activity or a lifestyle, in the general population using that therapy.


Longitudinal Surveillance Study of the 4-SITE Lead/Header System (LSS of 4-SITE)

The primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the Boston Scientific 4-SITE Lead/Header System used in the prevention of Sudden Cardiac Arrest.

The study has been approved by the Mount Hospital Ethics Committee.

        RECRUITMENT COMPLETED.



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