| November 30, 2007 |
| February 26, 2009 |
| January 2009 |
| December 2009 (final data collection date for primary outcome measure) |
- Reduction of the estimated 10-year total cardiovascular risk score [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
- Side effects (complaints) [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
- Adherence [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
|
| 1- Reduction of the estimated 10-year total cardiovascular risk score
2- Side effects (complaints)
3- Adherence [ Time Frame: Six months ] [ Designated as safety issue: Yes ] |
| Complete list of historical versions of study NCT00567307 on ClinicalTrials.gov Archive Site |
- Recruitment process [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Physicians and patients acceptability to the polypill [ Time Frame: Six months ] [ Designated as safety issue: No ]
|
| 1- Recruitment process
2- Physicians and patients acceptability to the polypill [ Time Frame: Six months ] [ Designated as safety issue: No ] |
| |
| Polypill For Prevention of Cardiovascular Disease |
| The Feasibility of a Polypill Clinical Trial for Primary Prevention of Cardiovascular Disease: A Pilot Study |
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). 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. |
| |
| Phase II |
| Interventional |
| Prevention, Randomized, Open Label, Parallel Assignment |
| Cardiovascular Disease |
- Drug: Red Heart Pill 2b (Polypill)
- Other: Usual Care
|
| |
| |
| |
| Recruiting |
| 200 |
| March 2010 |
| December 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 40 Years and older |
| No |
|
|
| Sri Lanka |
| |
| NCT00567307 |
| Curt D. Furberg MD, PhD/ Professor, Wake Forest University School of Medicine |
| WFUBMC-IRB00004134, SLCTR/ 2007/012 |
| Wake Forest University |
- World Health Organization
- National Hospital of Sri Lanka
|
| Study Chair: |
Curt D Furberg, MD, PhD |
Wake Forest University |
|
| Study Director: |
Shanthi Mendis, MD, FRCP |
World Heath Organization |
|
| Principal Investigator: |
Elsayed Z Soliman, MD, MSc |
Wake Forest University |
|
|
| Wake Forest University |
| February 2009 |
