HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events
| ISRCTN | ISRCTN29503772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29503772 |
| ClinicalTrials.gov (NCT) | NCT00461630 |
| Clinical Trials Information System (CTIS) | 2006-001885-17 |
| Protocol serial number | CTSUTHRIVE1 |
| Sponsor | University of Oxford (UK) |
| Funder | Merck &Co., Inc (USA) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Clinical Trial Service Unit (CTSU)
Richard Doll Building
University of Oxford
Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events |
| Study acronym | HPS2-THRIVE |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | ER niacin/laropiprant |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
The effects of allocation to ER niacin/laropiprant 2 g versus placebo during the scheduled treatment period on separate components of the primary endpoint: |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 25673 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
- China
- Denmark
- Finland
- Norway
- Sweden
Study participating centre
OX3 7LF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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? |
|---|---|---|---|---|---|
| Results article | results | 17/07/2014 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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).
