HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events): A randomized trial of the long-term clinical effects of raising HDL cholesterol with niacin and MK-0524. - HPS2-THRIVE

• Conditions: Cardiovascular disease: History of myocardial infarction; or cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation); or peripheral arterial disease (i.e. intermittent claudication or history of revascularisation); or diabetes mellitus with any of the above or with other evidence of symptomatic coronary heart disease.; MedDRA version: 9.0Level: LLTClassification code 10051615

• Registration Number: EUCTR2006-001885-17-FI
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-28
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

•History of myocardial infarction; or
•Cerebrovascular atherosclerotic disease (history of presumed ischaemic stroke, transient ischaemic attack or carotid revascularisation); or
•Peripheral arterial disease (i.e. intermittent claudication or history of revascularisation); or
•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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age <50 or >80 years at invitation to Screening;
•Less than 3 months since presentation with acute myocardial infarction, coronary syndrome or stroke (but such patients may be entered later, if appropriate);
•Planned revascularisation procedure within 3 months after randomization (but such patients may be entered later, if appropriate);
•Definite history of chronic liver disease, or abnormal liver function (i.e. ALT >1.5xULN). (Note: Patients with a history of acute hepatitis are eligible provided this ALT limit is not exceeded);
•Breathlessness at rest for any reason;
•Severe renal insufficiency (or creatinine >200 µmol/L);
•Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or CK >3xULN;
•Previous significant adverse reaction to a statin, ezetimibe, niacin or MK-0524;
•Active peptic ulcer disease;
•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
-any potent CYP3A4 inhibitor, including: macrolide antibiotics (erythromycin, clarithromycin, telithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease inhibitors (antiretroviral drugs for HIV infection); and nefazodone
-ciclosporin
-amiodarone
-verapamil
-danazol
(Note: Patients who are temporarily taking such drugs may be re-screened when they discontinue them, if considered appropriate.);
•Known to be poorly compliant with clinic visits or prescribed medication;
•Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer or evidence of spread within last 5 years other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified