Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461630
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2007-04-17
Brief Title:
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Randomized Trial of the Long-term Clinical Effects of Raising HDL Cholesterol With Extended Release NiacinLaropiprant
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPS2-THRIVE
Brief Summary:
The primary aim is to assess the effects of raising HDL cholesterol the good type with extended release niacinlaropiprant 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 niacinlaropiprant 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
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 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 laropiprantwhich 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
HDL cholesterol has long been known to have a strong inverse correlation with coronary heart disease CHD risk But randomized trial evidence for beneficial effects from raising HDL cholesterol is limited One of the most effective HDL-raising agents is niacin but the tolerability of niacin has been severely limited by flushing and cutaneous side-effects which appear to be mediated largely by prostaglandin D Laropiprant is a selective prostaglandin D receptor antagonist that substantially reduces the frequency and intensity of niacin-induced flushing Daily oral doses of extended release ER niacin plus Laropiprant 2gformerly MK-0524A have been well tolerated in early studies and increase HDL cholesterol by 20-25 The trial will assess whether this increase in HDL cholesterol translates into clinical benefit as is expected from the observational evidence In addition all participants will also be provided with effective LDL-lowering therapy as either simvastatin 40mg daily alone or with ezetimibe 10mg daily in a combination tablet
The complementary effects on the HDL good and LDL bad cholesterol produced by extended release niacinlaropiprant 2 g daily and simvastatin 40 mg with or without ezetimibe 10 mg should provide an excellent treatment option for patients with vascular disease However no trials so far have demonstrated clearly that raising HDL cholesterol produces the expected reduction in cardiovascular risk If HPS2-THRIVE is able to demonstrate reliably that raising HDL cholesterol reduces the risk of further cardiovascular events then this will be relevant to hundreds of millions of people worldwide
HDL cholesterol has long been known to have a strong inverse correlation with coronary heart disease CHD risk But randomized trial evidence for beneficial effects from raising HDL cholesterol is limited One of the most effective HDL-raising agents is niacin but the tolerability of niacin has been severely limited by flushing and cutaneous side-effects which appear to be mediated largely by prostaglandin D Laropiprant is a selective prostaglandin D receptor antagonist that substantially reduces the frequency and intensity of niacin-induced flushing Daily oral doses of extended release ER niacin plus Laropiprant 2gformerly MK-0524A have been well tolerated in early studies and increase HDL cholesterol by 20-25 The trial will assess whether this increase in HDL cholesterol translates into clinical benefit as is expected from the observational evidence In addition all participants will also be provided with effective LDL-lowering therapy as either simvastatin 40mg daily alone or with ezetimibe 10mg daily in a combination tablet
The complementary effects on the HDL good and LDL bad cholesterol produced by extended release niacinlaropiprant 2 g daily and simvastatin 40 mg with or without ezetimibe 10 mg should provide an excellent treatment option for patients with vascular disease However no trials so far have demonstrated clearly that raising HDL cholesterol produces the expected reduction in cardiovascular risk If HPS2-THRIVE is able to demonstrate reliably that raising HDL cholesterol reduces the risk of further cardiovascular events then this will be relevant to hundreds of millions of people worldwide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001885-17 | EUDRACT_NUMBER | None | None |
| ISRCTN29503772 | None | None | None |