Improving Adherence using Combination Therapy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12606000067572
• Date of registration: 16/02/2006
• Prospective Registration: Yes
• Primary sponsor: Health Research Council of New Zealand
• Public title: Improving Adherence using Combination Therapy
• Scientific title: Does a polypill improve cardiovascular guideline implementation in primary care in those at high risk of cardiovascular disease
• Date of first enrolment: 08/07/2010
• Target sample size: 600
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12606000067572.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

New Zealand

Contacts

• Name: Ms Angela Wadham

• Name: Dr Vanessa Selak

Key inclusion & exclusion criteria

Inclusion criteria: 1. Adults with 5-year cardiovascular risk of at least 15%2. The General Practitioner has the opinion that all the medications in at least one of the polypills are indicated3. The General Practitioner has uncertainty whether therapy is best provided as a polypill or with usual care4. The participant is able to give informed consent.
Exclusion criteria: 1. Contraindication to any of the components of the relevant combination capsule 2. Confirmed clinical diagnosis of congestive heart failure (CHF) or currently treated CHF 3. Documented haemorrhagic stroke 4. Active stomach or duodenal ulcer 5. On warfarin 6. The General Practitioner has the opinion that changing a patient's cardiovascular medications would put the patient at risk 7. Known situation where medication regimen might be altered for a significant length of time 8. Unlikely to complete the trial or the trial procedures.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Normal development and function of the cardiovascular system

High risk of cardiovascular disease;
High risk of cardiovascular disease

Intervention(s)

Polypill-based care for 12 months until the last participant has been randomised. In the polypill arm, one polypill (a capsule) is to be taken orally, once a day. 2 versions of polypill (choice of which at the discretion of the General Practitioner): Version 1: One capsule contains aspirin 75mg, simvastatin 40mg, lisinopril 10mg and atenolol 50mg; Version 2: One capsule contains aspirin 75mg, simvastatin 40mg, lisinopril 10mg and hydrochlorothiazide 12.5mg

Primary Outcome(s)

2. Blood pressure change[Over 1 year]

1. Adherence (self-reported current use of antiplatelet, statin and combination (2+) blood pressure lowering therapy)[At 1 year]

3. LDL-cholesterol change[Over 1 year]

Secondary Outcome(s)

3. Serious adverse events[Over trial duration (until 12 months after the last participant has been randomised)]

9. Symptoms causing withdrawal of cardivoascular medications[Over trial duration (until 12 months after the last participant has been randomised)]

2. Barriers to adherence[Over trial duration (until 12 months after the last participant has been randomised)]

6. Prescriber acceptabitility[Over trial duration (until 12 months after the last participant has been randomised)]

4. Cardiovascular events[Over trial duration (until 12 months after the last participant has been randomised)]

Dispensing of statin and 2+ blood pressure lowering agents[Over trial duration (until 12 months after the last participant has been randomised)]

Blood pressure change (if able to be assessed beyond 1 year; will be assessed by automatic sphygmomanometer)[Over trial duration (until 12 months after the last participant has been randomised)]

Change in other lipid fractions (High density lipoprotein [HDL]-cholesterol, total cholesterol, triglycerides) (if able to be assessed beyond 1 year; will be assessed by blood analysis)[Over trial duration (until 12 months after the last participant has been randomised)]

7. Change in other lipid fractions (HDL-cholesterol, total cholesterol, triglycerides)[At 1 year]

Adherence (self-reported current use of antiplatelet, statin and combination (2+) blood pressure lowering therapy)[Over trial duration (until 12 months after the last participant has been randomised)]

Dispensing of statin and 2+ blood pressure lowering agents (to be assessed via data linkage to national database)[At 1 year]

8. Healthcare resource consumption and cost-effectiveness[Over 1 year]

Low density lipoprotein (LDL)-cholesterol change (if able to be assessed beyond 1 year; will be assessed by blood analysis)[Over trial duration (until 12 months after the last participant has been randomised)]

Quality of life (EQ5D)[Over trial duration (until 12 months after the last participant has been randomised)]

Secondary ID(s)

Nil

Source(s) of Monetary Support

The National Heart Foundation of New Zealand (research fellowship)

Health Research Council of New Zealand (project grant)

Ethics review

Status: Approved
Approval date:
Contact:

Health and Disability Ethics Committee