To assess whether provision of the Red Heart polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) compared to usual cardiovascular medications improves adherence to indicated medicines and clinical outcomes in…
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
Adherence to indicated medications (defined as self-reported current use of
antiplatelet, statin and combination (>= 2) blood pressure lowering therapy),
change in blood pressure, change in LDL-cholesterol, at end of trial
Secondary outcome
Dispensing of statin and >= 2 blood pressure lowering agents, self-reported
barriers to adherence, serious adverse events, cardiovascular events, reasons
for stopping cardiovascular medications, quality of life, change in other lipid
fractions (HDL-cholesterol, total- cholesterol, triglycerides), and comparison
of results in Europe and India.
Background summary
Cardiovascular disease is the world*s biggest killer and leading cause of loss
of healthy life years. People with established vascular disease represent a
target for secondary prevention using combination therapy that addresses
multiple risk factors. Barriers to effective delivery of proven secondary
preventative treatments create important gaps in the uptake. These gaps vary
in different countries. Complexity and cost of treatment confer particularly
difficult barriers; typically an individual recovering from a stroke or heart
attack might be advised to take multiple medications to address cholesterol,
blood pressure and platelet function. A combination once daily polypill may
address these issues. Such a pill, the Red Heart Pill, has been formulated by
Dr Reddy*s Laboratories in India. It would be relatively inexpensive.
Study objective
To assess whether provision of the Red Heart polypill (containing low dose
aspirin, a statin and two blood pressure lowering medicines) compared to usual
cardiovascular medications improves adherence to indicated medicines and
clinical outcomes in high-risk patients at end of trial follow-up.
Study design
Open label, randomised, controlled trial (n=2000)
Intervention
Eligible participants willing to participate in this trial will be randomised
to at least 12 months treatment with the polypill or to continued usual care:
* Polypill:
Red Heart Pill version 1: - aspirin 75mg, simvastatin 40mg, lisinopril 10mg,
atenolol 50mg;
Red Heart Pill version 2: - aspirin 75mg, simvastatin 40mg, lisinopril 10mg,
hydrochlorothiazide 12.5mg.
The choice of polypill version will be at the discretion of the Trial
Investigator. Treatment will be continued until 12 months after the last
participant has been randomised.
* Usual care: Usual cardiovascular preventive medications (e.g. antiplatelet,
blood pressure lowering and cholesterol lowering as separate medicines) as
prescribed by the treating doctor.
The treating doctor will be encouraged to prescribe in line with local
cardiovascular disease prevention guidelines for both groups. All changes to
medication following the randomisation visit in both groups will be at the
discretion of the treating doctor.
Study burden and risks
Measurements:
None of the study measurements are dangerous. Routine blood samples taken may
be associated with somen bruising, discomfort and local irritation. There is
also a smal risk of infection whennever the skin is broken by a needle. CIMT,
elastography and one of the PWV/PWA measurements may be incomfortable due to
lying down flat for some time, but is not painfull. The ABPM may be
incomfortable due to 24 hours measurement every 30 minutes, including at night.
This last measurement may be inconvenient.
Medication:
The polypill combination cardiovascular medication will be an unapproved
medication. However all the ingredients in both of the polypill combinations
used in this trial are well knowm midicines with well established efficacy and
safety profiles.
Although all the drugs in the polypill haven been used for many years there are
possible risks that both polypill may cause side effects. These are generally
mild and infrequent and are usally resolved immediatly by stopping the
medication. Side effects of the components of the polypills can include low
bloodpressure, dizziness, headache, nausea, mild stomach pain, heartburn,
ulceration, abdominal pain, constipation, flatulance, bleeding, gout, cough,
fatique, liver problems, ans 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
Individuals are eligible for inclusion if all of the following criteria are satisfied:
- adults ( equal of older than 18 years)
- The participant is able to give informed consent
- Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, defined as;
* History of coronary heart disease ( myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure) or
* History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or
*History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease), or
* For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15 % or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations).
- The trial investigator considers that each of the polypill components are indicated
- The trial investigator is unsure as to whether a polypill-based strategy or usual care is better.
Exclusion criteria
Individuals will NOT be eligible if one or more of the following criteria are satisfied: ;• Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors; pregnancy or likely to become pregnant or breastfeeding women during the treatment period). Such contrindications are fully listed in the Investigator Brochures.;• The treating doctor considers that changing a participant*s cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose β-blocker required to manage angina or for rate control in atrial fibrillation, accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension). ;Other potential reasons for exclusion include: ;• Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation. ;• Unlikely to complete the trial (e.g. life-threatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia). ;Women of child bearing potential should be on a medically accepted form of contraception (oral or implanted contraception, IUD or tubal sterilisation). If there is any possibility of pregnancy, prior to randomisation a blood or urine pregnancy test will be performed. Final decisions about eligibility will be made at the discretion of the trial Investigator and potential trial participant, in light of any additional requirements or guidance from local ethics committees and other regulatory bodies.
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 |
|---|---|
| EudraCT | EUCTR2009-016278-34-NL |
| ClinicalTrials.gov | NCT01057537 |
| CCMO | NL29865.041.10 |