Condition category
Circulatory System
Date applied
24/01/2007
Date assigned
01/03/2007
Last edited
23/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctsu.ox.ac.uk/~thrive/

Contact information

Type

Scientific

Primary contact

Prof Jane Armitage

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00461630

Protocol/serial number

CTSUTHRIVE1

Study information

Scientific title

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

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

Local ethics committee (MREC), 04/08/2006, ref: 06/MRE12/43

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

http://www.ctsu.ox.ac.uk/~thrive/participants.htm

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

Phase

Not Applicable

Drug names

ER niacin/laropiprant

Primary outcome measures

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 trial start date

01/08/2007

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

25,673

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, Finland, Norway, Sweden, United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Merck &Co., Inc (USA)

Alternative name(s)

Merck & Co., Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00461630

Publication summary

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

Publication citations

Additional files

Editorial Notes

As of 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).