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.
Lonn
E M
EM
Division of Cardiology and Preventive Cardiology, Hamilton Civic Hospitals Research Center, McMaster University, Ontario, Canada.
Yusuf
S
S
Doris
C I
CI
Sabine
M J
MJ
Dzavik
V
V
Hutchison
K
K
Riley
W A
WA
Tucker
J
J
Pogue
J
J
Taylor
W
W
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