Polypill for cardiovascular prevention

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2007/012
• Date of registration: 19/10/2007
• Primary sponsor: World Health Organization Headquarter Wake Forest University School of Medicine
• Public title: Polypill for cardiovascular prevention
• Scientific title: The feasibility of a polypill clinical trial for primary prevention of cardiovascular disease (A pilot study)
• Date of first enrolment: 1/10/2007
• Target sample size: 200
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={D4C0FE3F-5621-487C-B887-2713266CFC53}
• Study type: Interventional
• Study design: Randomized controlled clinical trial

Countries of recruitment

Sri Lanka, Malawi

Contacts

• Name: Curt D. Furberg MD PhD
• Affiliation: Professor

• Name: Dr. Padma Gunaratne
• Affiliation: Consultant Neurologist

Key inclusion & exclusion criteria

Inclusion criteria: More than 40 years
Estimated 10-year total CVD risk score and#8805; 30%. (The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts)
No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins.
Informed consent given
Exclusion criteria: Patients with established angina pectoris, coronary heart disease, myocardial infraction, transient ischemic attacks, stroke, peripheral vascular disease, coronary
revascularization and /or carotid endarterectomy
Left ventricular hypertrophy (on ECG) or hypertensive
retinopathy (grade three or four)
Patients with secondary hypertension
Patients with diabetes type 1 or 2 with overt neuropathy
or other significant renal disease
Known renal failure or impairment
Atrial fibrillation
ALT > 1.5 times the upper limit of normal
History of liver cirrhosis or hepatitis
History of recent gastrointestinal bleeding (within the last year)
Women of child bearing age
History of life-limiting diseases or events
Unwillingness to sign informed consent

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Cardiovascular disease

Intervention(s)

Intervention arm: Poplypill which is a combination of low dose aspirin, simvastatin, HCT and lisinopril control arm: usual care

Primary Outcome(s)

-Reduction in the estimated 10 year cardiovascular risk
-Adherence to the study medication throughout the study (3 months)
-Tolerability (the proportion of participants who withdraw due to side effects

Secondary Outcome(s)

•Acceptability of the polypill by physicians and patients
•Introducing the newly developed WHOcardiovascular risk prediction charts
•Improving the knowledge of participants to theircardiovascular risk factors
•Building an infrastructure for internationalcollaborative research in cardiovascular disease

Secondary ID(s)

1.WHO ethical approval: Under processing 2.Licence No to import drug: S-016715

Source(s) of Monetary Support

World Health Organization Headquarter Department of Chronic Diseases and Health Promotion (CHP), Geneva, Switzerland-partial fund Wake Forest University School of Medicine Division of Public Health Sciences, Winston Salem NC, USA Dr Reddy’s laboratories limited, India

Secondary Sponsor(s)

Dr Reddy’s laboratories limited