Phase 2
Completed N=216
Polypill For Prevention of Cardiovascular Disease
Source: ClinicalTrials.gov NCT00567307 ↗Enrolled (actual)
216
Serious AEs
27.1%
Results posted
Dec 2016
Primary outcomePrimary: Reduction of the Estimated 10-year Total Cardiovascular Risk Score — 11.5; 11.1 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of the Estimated 10-year Total Cardiovascular Risk Score |
11.5; 11.1 | — |
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.
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. Informational only — not medical advice.