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02 September 2010
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| [ ...Back to search results ] | [ Print-friendly version ] |
| HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events |
| ISRCTN | ISRCTN29503772 |
| ClinicalTrials.gov identifier | NCT00461630 |
| Public title | HPS2-THRIVE: Treatment of High density lipoprotein to Reduce the Incidence of Vascular Events |
| Scientific title | |
| Acronym | HPS2-THRIVE |
| Serial number at source | CTSUTHRIVE1 |
| 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 | Approval received from the local ethics committee (MREC) on the 4th August 2006 (ref: 06/MRE12/43). |
| Study design | Randomised double-blind placebo controlled trial |
| Countries of recruitment | China, Denmark, Finland, Norway, Sweden, United Kingdom |
| Disease/condition/study domain | Cardiovascular disease |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/08/2007 |
| Anticipated end date | 01/01/2013 |
| Status of trial | Ongoing |
| Patient information material | Can be found at http://www.ctsu.ox.ac.uk/~thrive/ |
| Target number of participants | Amended 26/07/2010: 25,673 participants randomised. |
| Interventions |
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.
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). |
| 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. |
| 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:
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 |
| Sources of funding | Merck &Co., Inc (USA) |
| Trial website | http://www.ctsu.ox.ac.uk/~thrive/ |
| Publications | |
| Contact name | Prof Jane Armitage |
| Address |
Clinical Trial Service Unit (CTSU)
Richard Doll Building University of Oxford Old Road Campus, Roosevelt Drive |
| City/town | Oxford |
| Zip/Postcode | OX3 7LF |
| Country | United Kingdom |
| Sponsor | University of Oxford (UK) |
| Address |
University Offices
Wellington Square |
| City/town | Oxford |
| Zip/Postcode | OX1 2JD |
| Country | United Kingdom |
| Date applied | 24/01/2007 |
| Last edited | 26/07/2010 |
| Date ISRCTN assigned | 01/03/2007 |
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