A randomised placebo-controlled trial of fixed-dose combination medication in those at raised risk of cardiovascular disease - PILL Pilot

Phase 1

• Conditions: Cardiovascular Disease; MedDRA version: 9.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecified

• Registration Number: EUCTR2007-002466-35-NL
• Lead Sponsor: Imperial Ciollege

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-11
• Study Completion: 2009-12-22
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 378

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 – <7.5% risk would also be eligible with two additional risk factors of:
oBody mass index >30 kg/m2, waist circumference >102 cm in men or >88 cm in women
oHeart rate >80 beats/min
oFasting glucose 5.6 - <7.0 mmol/L
oTriglycerides >1.7 mmol/l
oFamily 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
oGlomerular filtration rate (GFR) <60 ml/min
•No indication or contraindication for use of low-dose aspirin, ACE inhibitor, low-dose diuretic or statin.
•The participant is able to give informed consent.

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

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

Study & Design

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