To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill in individuals with raised risk of a cardiovascular event.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the efficacy (systolic blood pressure, LDL cholesterol) and
tolerability (the proportion who withdraw from trial treatment).
Secondary outcome
Treatment adherence (measured by pill count), diastolic blood pressure, total
cholesterol, HDL cholesterol, total cholesterol:HDL cholesterol ratio, non HDL
cholesterol, triglycerides, frequency of switching to open-label treatment,
estimated CVD risk, serious adverse events and all adverse events.
Background summary
One of the most hotly debated issues in cardiovascular disease (CVD) research
is whether a *polypill* (a new combination cardiovascular medication containing
aspirin and agents to lower blood pressure and cholesterol) can really reduce
CVD by three-quarters or more. To assess this reliably will require a long term
clinical trial of many thousands of participants. This protocol is for a pilot
trial that will assess the efficacy and tolerability of the polypill.
Study objective
To measure the efficacy (change in systolic blood pressure and LDL cholesterol)
and tolerability of a polypill in individuals with raised risk of a
cardiovascular event.
Study design
Randomised, placebo-controlled, parallel-group trial (n=400)
Intervention
Eligible individuals willing to participate in the trial will be randomised to
12 weeks treatment with the polypill or to an identical matching placebo:
* Polypill: aspirin 75mg, simvastatin 20mg, lisinopril 10mg,
hydrochlorothiazide 12.5mg.
* Placebo: identical matching placebo.
Both groups will also receive information about smoking cessation (if
applicable) and how to follow a healthy heart diet. They will be advised to
increase physical activity and lose weight if needed.
Study burden and risks
Measurements:
None of the study measures are dangerous. Routine blood samples taken may be
associated with some bruising, discomfort and local irritation. There is also
a small risk of infection whenever the skin is broken by a needle.
Medication:
The polypill combination cardiovascular medication will be an unapproved
medication. However all the ingredients of the polypill combinations used in
the trial are well known medicines with well established efficacy and safety
profiles.
Although all the drugs in the polypill have been used for many years there are
possible risks that the polypill or placebo may cause side effects. These are
generally mild and infrequent and are usually resolved immediately by stopping
the medication. Side effects of the components of the polypill can include low
blood pressure, dizziness, headache, nausea, mild stomach pain, heartburn,
ulceration, abdominal pain, constipation, flatulence, bleeding, gout, cough,
fatigue, liver problems, and muscle pain, tenderness or weakness. As with any
medication, an allergic reaction is possible such as skin rash, itching,
difficulty breathing or swelling of the face, but this is quite rare.
Bolognalaan 12
3584 CJ Utrecht
NL
Bolognalaan 12
3584 CJ Utrecht
NL
Listed location countries
Age
Inclusion criteria
Adults (> 18 years) with a cardiovascular disease (CVD) risk over 5 years of at least 7.5%, determined by the Framingham risk function (Anderson, 1991) using data on age, gender, blood pressure, total cholesterol, HDL cholesterol, diabetes status and cigarette smoking status.
Exclusion criteria
Clear indication for antiplatelet, blood pressure lowering or cholesterol lowering medications. This includes: current treatment with blood pressure or cholesterol lowering medicines, diabetes mellitus, existing CVD, or individuals with LDL cholesterol, systolic blood pressure or estimated CVD risk values above those recommended for treatment by local guidelines.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ACTRN012607000099426 |
| EudraCT | EUCTR2007-002466-35-NL |
| CCMO | NL20733.041.07 |