Cardiovascular disease: History of myocardial infarction
Conditions
Interventions
Product Name: MK-0524A (ER-Niacin/MK-0524) 1g/20 mg Tablets
Product Code: MK-0524A (ER-Niacin/MK-0524) 1g/20 mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Spo
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: •Age 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to assess the effect of raising HDL-cholesterol with extended release niacin 2 g plus MK-0524 40 mg daily (denoted “MK-0524A 2 g”) versus placebo on the time to first “major vascular event” (defined as non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation).;Secondary Objective: Secondary aims include assessment of the effects of MK-0524A: on early safety outcomes; on the separate components of the primary endpoint; and on the primary endpoint within major baseline disease subgroups.;Primary end point(s): The primary comparison will involve an “intention-to-treat” analysis among all randomized patients using the “logrank” test23 of the effects of allocation to MK-0524A versus placebo on major vascular events during the scheduled treatment period of a median of at least 4 years. A major vascular event (MVE) is defined as the composite of non-fatal myocardial infarction or coronary death; non-fatal or fatal stroke; or any revascularisation procedure (including coronary or non-coronary angioplasty or grafting). | — |
Countries
Denmark, Finland, Sweden, United Kingdom
Outcome results
None listed