Cardiovascular Disease MedDRA version: 9.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified
Conditions
Interventions
Product Name: Polypill
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Imperial Ciollege
St Mary's NHS Trust
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The trial targets individuals who have an absolute risk of a major cardiovascular event in next 5 years of at least 7.5% but who do not meet current guidelines for treatment with aspirin, or BP-lowering or cholesterol-lowering medications. Individuals are eligible for inclusion if all of the following criteria are satisfied: • Adults (> 18 years) with a CVD risk over 5 years of at least 7.5%, determined by the Framingham risk function using data on age, gender, BP, total cholesterol, HDL cholesterol and cigarette smoking status. The Framingham risk function will be recalibrated for each country using local incidence data from the WHO Global Burden of Disease Project. Those with an estimated 5 year risk of 5.0 – 30 kg/m2, waist circumference >102 cm in men or >88 cm in women o Heart rate >80 beats/min o Fasting glucose 5.6 - 1.7 mmol/l o Family history of premature coronary heart disease or ischaemic stroke in a first degree male relative before the age of 55 years or a first degree female relative before the age of 65 years o Glomerular filtration rate (GFR) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Individuals will NOT be eligible if there is one or more of the following: • Clear indication for antiplatelet, BP lowering or cholesterol lowering medications. This includes: current treatment with BP or cholesterol lowering medicines, diabetes mellitus, existing CVD, or individuals with LDL cholesterol, systolic BP or estimated CVD risk values above those recommended for treatment by local guidelines. • Contraindication to any of the components of the polypill. • Life-limiting disease or events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the trial is to evaluate whether a “polypill” a fixed low dose combination of blood pressure lowering drugs (an ACE inhibitor and diurectic), cholesterol lowering drugs (a statin) and asprin results in improved systolic Blood Pressue and LDL-cholesterol(bad cholesterol) levels and is tolerable compared with placebo (a tablet containing no medication) in individuals at raised risk of 7.5% or more in the next 5 years of a major cardiovascular event, such as a heart attack or stroke. (This estimate is made by considering a number of factors including your age, gender, blood pressure, cholesterol level and whether you smoke). ;Secondary Objective: Secondary aims are to measure adherence, change in diastolic BP, total, HDL(good cholesterol) and non-HDL cholesterol, triglycerides, frequency of switching to open-label treatment, change in cardiovascular disease risk and adverse events. ;Primary end point(s): The main study outcomes are change in systolic blood pressure, change in LDL-cholesterol, adherence (self-reported and pill counts) and tolerability (the proportion who withdraw from study treatment). Secondary outcomes are change in diastolic blood pressure, total cholesterol and non-HDL cholesterol, frequency of switching to open-label treatment, change in CVD risk and adverse events. | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed