A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.
This was 2x2 factorial design study with 2 strata. As per protocol, the first co- Primary analysis as well as secondary analysis were aliskiren based regimen vs non-aliskiren based regimen. All aliskiren based arm were combined into the aliskiren based regimen and all non-aliskiren based arms were combined into non-aliskiren based regimen.
Inclusion Criteria:
Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3):
Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease
Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention):
Men and women aged ≥ 70 years if they do not have any of the above (primary prevention)
Exclusion Criteria:
Westfiled, New York 14787, United States
Buenos Aires, Buenos Aires 2800, Argentina
Buenos Aires, Buenos Aires 8000, Argentina
Buenos Aires, Buenos Aires C1425AWC, Argentina
Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma de Bs As, Buenos Aires C1119ACN, Argentina
Jenin, Buenos Aires 6000, Argentina
Missisauga, Ontario L4Y 1A6, Canada
North York, Ontario M2N 7J5, Canada
Saint Catherines, Ontario L2T 3Y4, Canada
St.Gorges de Beauce, Quebec G5Y 4TB, Canada
Vista Del Mar, Tarapacá 2570017, Chile
Temuca, TX 4790869, Chile
Manizoles, Caldas Department 1700, Colombia
Cartegena, Colombia, Colombia
Bogota, Cundinamarca, Colombia
Baranquilla, Colombia
Hyderabad, Andhra Pradesh 500004, India
Ballinsloe, Galway, Ireland