HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events

Not Applicable

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN29503772
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25014686 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-01
• Study Completion: 2013-01-01
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25673

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified