High Cholesterol

Why is this study being conducted?

Cardiovascular disease is one of the leading causes of morbidity and mortality in the UK, as well as in the developed and the developing world. Finding new and safe treatments to reduce the burden of heart disease and strokes is therefore an important contribution to public health and in the wider public interest. HPS2-THRIVE aims to find out whether by combining niacin (a drug that has been available for 50 years) with a new drug laropiprant(which reduces the side-effects of niacin) is beneficial. All participants in HPS2-THRIVE will have established cardiovascular disease and therefore be at very high risk of recurrent vascular events (myocardial infarction, stroke or the need for arterial revascularisation). Two of the most important risk factors for recurrent events in such patients are the blood levels of LDL cholesterol with a positive association, and HDL cholesterol levels with a negative association.

Purpose

The primary aim is to assess the effects of raising HDL cholesterol (the good type) with extended release niacin/laropiprant 2g (previously known as MK-0524A) versus matching placebo on the risk of heart attack or coronary death, stroke, or the need for arterial bypass procedures (revascularisation) in people with a history of circulatory problems. The secondary aim is to assess the effects of extended release niacin/laropiprant 2g daily on heart attack, coronary death, stroke, and revascularisation separately and to assess the effects on mortality both overall and in various categories of causes of death, and of the effects on major cardiovascular events in people with a history of different diseases at the beginning of the study.

What are the main eligibility criteria?

Inclusion Criteria:

• History of myocardial infarction; or
• Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation)
• Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation); or
• Diabetes mellitus with any of the above or with other evidence of symptomatic coronary heart disease (i.e. stable or unstable angina, or a history of coronary revascularisation or acute coronary syndrome).

Exclusion Criteria:

• Age <50 or >80 years at invitation to Screening;
• Less than 3 months since presentation with acute myocardial infarction, coronary syndrome or stroke (but such patients may be entered later, if appropriate);
• Planned revascularisation procedure within 3 months after randomization (but such patients may be entered later, if appropriate)

Important

If you are interested in participating in a clinical trial, please register and you will be contacted by the study coordinator or person involved with the specific trial you are interested in.

• Prior to your participation a physician will inform you about the process in detail and examine if you are eligible to take part in the study.
• If you are to participate all medication will be free.
• Of course you can terminate during the process any time.

References:

Trial information was taken from the following sites:

• http://www.clinicaltrials.gov/ct2/show/NCT00461630
• In ClinLife opinion the main facts were taken and centralized. ClinLife isn´t liable for defects or wrong translation.
• Official Title: A Randomized Trial of the Long-Term Clinical Effects of Raising HDL Cholesterol With Extended Release Niacin/Laropiprant