Status:
COMPLETED
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cardiovascular Disease
Peripheral Arterial Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE3
Brief Summary
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 he...
Detailed Description
Cardiovascular disease is one of the leading causes of morbidity and mortality in the United Kingdom (UK), as well as in the developed and the developing world. Finding new and safe treatments to redu...
Eligibility Criteria
Inclusion
- 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
- 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);
- Definite history of chronic liver disease, or abnormal liver function (i.e. Alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN). (Note: Patients with a history of acute hepatitis are eligible provided this ALT limit is not exceeded);
- Breathlessness at rest for any reason;
- Severe renal insufficiency (i.e. creatinine \>200 µmol/L);
- Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or Creatine kinase (CK) \>3 times upper limit of normal (3xULN);
- Previous significant adverse reaction to a statin, ezetimibe, niacin or laropiprant;
- Active peptic ulcer disease;
- 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
- any potent cytochrome P450 3A4 (CYP3A4) inhibitor, including: macrolide antibiotics (erythromycin, clarithromycin, telithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease inhibitors (antiretroviral drugs for HIV infection); and nefazodone
- ciclosporin
- amiodarone
- verapamil
- danazol (Note: Patients who are temporarily taking such drugs may be re-screened when they discontinue them, if considered appropriate.);
- Known to be poorly compliant with clinic visits or prescribed medication;
- Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer or evidence of spread within last 5 years other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
25673 Patients enrolled
Trial Details
Trial ID
NCT00461630
Start Date
January 1 2007
End Date
October 1 2012
Last Update
February 28 2014
Active Locations (1)
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1
Clinical Trial Service Unit, University of Oxford
Oxford, United Kingdom, OX3 7LF