Study design and baseline characteristics of the study to evaluate carotid ultrasound changes in patients treated with ramipril and vitamin E: SECURE.
Atherosclerotic cardiovascular disease remains a major cause of mortality and morbidity in most developed countries. Experimental and clinical evidence suggests that angiotensin-converting enzyme inhibitors and vitamin E therapy may retard the atherosclerotic process; however, definitive proof in humans is lacking. The Study to Evaluate Carotid Ultrasound Changes in Patients Treated with Ramipril and Vitamin E (SECURE) is designed to assess the effects of ramipril--an angiotensin-converting enzyme inhibitor, at 2 doses: 2.5 mg daily (which has little effect on lowering blood pressure) and 10 mg daily--and the antioxidant vitamin E, 400 IU daily, on atherosclerosis progression in 732 patients using a factorial 3 x 2 study design. High-risk patients with a documented history of significant cardiovascular disease or with diabetes and additional risk factors were enrolled and will be followed for 4 years. The extent and progression of atherosclerosis are assessed noninvasively by B-mode carotid ultrasonography. The SECURE trial is a substudy of the larger Heart Outcomes Prevention Evaluation (HOPE) study of 9,541 high-risk patients evaluating the effects of ramipril and vitamin E on major cardiovascular events (cardiovascular death, myocardial infarction, and stroke). The 2 studies are complementary. Whereas HOPE is expected to provide information on major clinical outcomes, SECURE will shed light on the mechanisms by which these effects may be mediated.
Division of Cardiology and Preventive Cardiology, Hamilton Civic Hospitals Research Center, McMaster University, Ontario, Canada.
E M
EM
Lonn
S
S
Yusuf
C I
CI
Doris
M J
MJ
Sabine
V
V
Dzavik
K
K
Hutchison
W A
WA
Riley
J
J
Tucker
J
J
Pogue
W
W
Taylor
D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D001161:Arteriosclerosis / Q000188:drug therapy*; D002340:Carotid Artery Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy*; D003324:Coronary Artery Disease / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008297:Male; D017257:Ramipril / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D012307:Risk Factors; D014463:Ultrasonography; D014810:Vitamin E / Q000627:therapeutic use*
D000806:Angiotensin-Converting Enzyme Inhibitors; D014810:Vitamin E; D017257:Ramipril