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

ISRCTN	ISRCTN29503772
DOI	https://doi.org/10.1186/ISRCTN29503772
EudraCT/CTIS number	2006-001885-17
ClinicalTrials.gov number	NCT00461630
Secondary identifying numbers	CTSUTHRIVE1

Submission date: 24/01/2007
Registration date: 01/03/2007
Last edited: 30/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Jane Armitage
Scientific

Clinical Trial Service Unit (CTSU)
Richard Doll Building
University of Oxford
Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom

Study information

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	http://www.ctsu.ox.ac.uk/~thrive/participants.htm
Scientific title	HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events
Study acronym	HPS2-THRIVE
Study hypothesis	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?
Ethics approval(s)	Local ethics committee (MREC), 04/08/2006, ref: 06/MRE12/43
Condition	Cardiovascular disease
Intervention	ER niacin/laropiprant 2 g daily versus matching placebo tablets. All patients receive LDL lowering therapy with either 40 mg of simvastatin or 10/40 mg ezetimibe/simvastatin.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	ER niacin/laropiprant
Primary outcome measure	The effects of allocation to ER niacin/laropiprant 2 g versus placebo on major vascular events during the scheduled treatment period of at least four years.
Secondary outcome measures	The effects of allocation to ER niacin/laropiprant 2 g versus placebo during the scheduled treatment period on separate components of the primary endpoint: 1. Major coronary events 2. Total stroke 3. Revascularisation 4. Mortality, both overall and within particular categories of causes of death, and major vascular events in patients with coronary heart disease 5. Peripheral arterial disease 6. Cerebrovascular disease or diabetes mellitus
Overall study start date	01/08/2007
Overall study end date	01/01/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	25,673
Participant 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)
Participant 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
Recruitment start date	01/08/2007
Recruitment end date	01/01/2013

Locations

Countries of recruitment

China
Denmark
England
Finland
Norway
Sweden
United Kingdom

Study participating centre

University of Oxford

Oxford
OX3 7LF
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

"ROR"	https://ror.org/052gg0110

Funders

Funder type

Industry

Merck &Co., Inc (USA)
Government organisation / For-profit companies (industry)

Alternative name(s): Merck & Co., Inc., Merck & Co.
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	17/07/2014		Yes	No

Editorial Notes

30/08/2022: A long-term follow-up study of HPS2-THRIVE has been registered as ISRCTN39960384.
20/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
26/07/2010: This record was updated to include details of the completed randomisation phase - 25,673 participants were randomised at the end of this phase. The previously anticipated target number of randomisations was 25,000 (as of 28/10/2009), and the initial target number of randomisations was 20,000 (at time of registration).