HPS2-THRIVE
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
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Status:
This study is currently recruiting participants.
Purpose:
Does niacin combined with Extended Release (ER) niacin/laropiprant 2 g daily prevent vascular events in high-risk patients who are receiving intensive Low Density Lipoprotein (LDL)-lowering treatment?
Interventions:
Niacin Extended Release
organic compound used to improve blood cholesterol or lower fats (called triglycerides or lipids) in the blood.
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Statin
The statins (or HMG-CoA reductase inhibitors) form a class of hypolipidemic drugs used to lower cholesterol levels in people with or at risk of cardiovascular disease.
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Location(s):
China, Denmark, Finland, Norway, Sweden, United Kingdom
Year Started:
2007
Design:
Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Inclusion Criteria
Sufferers of one of the following:
1. History of myocardial infarction
2. Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation)
3. Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation)
4. 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
1. Age less than 50 or more than 80 years at invitation to screening
2. Less than three months since presentation with acute myocardial infarction, coronary syndrome or stroke
3. Planned revascularisation procedure within three months after randomisation
4. Definite history of chronic liver disease, or abnormal liver function (i.e. Alanine Aminotransferase [ALT] more than 1.5 x Upper Limit of Normal [ULN])
5. Breathlessness at rest for any reason
6. Severe renal insufficiency (i.e. creatinine more than 200 µmol/L)
7. Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or Creatine Kinase [CK] more than 3 x ULN
8. Previous significant adverse reaction to a statin, ezetimibe, niacin or ER niacin/laropiprant 2 g
9. Active peptic ulcer disease
10. Concurrent treatment with: fibric acid derivative ('fibrate'), niacin (nicotinic acid) at doses more than 100 mg daily, ezetimibe in combination with either simvastatin 80 mg or atorvastatin 20 - 80 mg or rosuvastatin 10 - 40 mg daily, or any potent CYP3A4 inhibitor
Patient Involvement:
Patients will be randomized to one of two arms: 1)ER niacin/laropiprant 2 g daily versus 2) matching placebo tablets. All patients receive LDL lowering therapy with either 40 mg of simvastatin or 10/40 mg ezetimibe/simvastatin. All patients will have baseline LDL & HDL blood levels and be followed with blood samples at prescribed intervals during study.
Primary Outcome:
Time to first major vascular event (defined as non-fatal myocardial infarction or coronary death non-fatal or fatal stroke, or revascularisation) by the end of study
Secondary Outcome:
Major vascular events (non-fatal MI or cardiac death) by the end of the study; stroke (fatal or non-fatal) by the end of the study; coronary or non-coronary revascularisation by the end of the study; mortality, both overall and in particular categories of causes of death; major cardiovascular events in people with a history of different diseases at the beginning of the study.
Source of Information:
ClinicalTrials.gov
ControlledTrials.com
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Web Links and Publications:
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This information last updated on: 10/16/2009
Reviewed on: 10/14/2009.
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