Phase 2 N=216 Randomized Prevention

Polypill For Prevention of Cardiovascular Disease

Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT00567307 ↗

Enrolled (actual)

216

Serious AEs

27.1%

Results posted

Dec 2016

Primary outcome: Primary: Reduction of the Estimated 10-year Total Cardiovascular Risk Score — 11.5; 11.1 percent

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Red Heart Pill 2b (Polypill) (Drug); Standard Practice (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction of the Estimated 10-year Total Cardiovascular Risk Score	11.5; 11.1	—

Summary

The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.

Eligibility Criteria

Inclusion Criteria

Estimated 10-year total CVD risk score > 20%. 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 infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
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 in child bearing period
History of life-limiting diseases or events
Unwillingness to sign informed consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00567307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.