Study to Evaluate Carotid Ultrasound Changes in Patients Treated with Ramipril and Vitamin E - SECURE
Ramipril and vitamin E for atherosclerotic progression in CAD.
To assess whether ramipril and vitamin E decrease the rate of progression of atherosclerotic disease rate of progression of atherosclerotic arterial disease.
Patients Screened: Not given
Patients Enrolled: 732
Mean Follow Up: Planned 4 years
Mean Patient Age: 65.4
Age greater or equal to 55 years
Acquisition of high-quality ultrasound images allowing reliable measurements from a minimum of 4 predefined segments per patient.
Documented coronary artery disease (previous MI, angina with documented multivessel CAD, previous angioplasty and multivessel CAD, multivessel coronary artery bypass graft surgery performed greater than 4 years before study enrollment), or
Documented peripheral vascular disease (previous limb bypass surgery or angioplasty, previous limb amputation, history of intermittent claudication, and ankle or arm blood pressure ratio of less or equal to 0.80), or history of nondebilitating stroke or diabetes with at least 1 additional risk factor.
Atherosclerosis progression as assessed by quantitative carotid B-mode ultrasound
The effect of combined treatment with ACE inhibitors and vitamin E compared with placebo or either intervention alone.
The effect of full-dose ramipril (10 mg daily) versus low-dose ramipril (2.5 mg daily), (to assess impact of ACE inhibition independent of blood pressure changes)
Effect of ACE inhibitors and vitamin E on CV death, MI, ischemic stroke, unstable angina, limb amputation, and revascularization procedures.
Ramipril 2.5mg daily, Ramipril 10mg daily, and vitamin E 400 IU daily using a factorial 3 X 2 study design.
Use of all cardioactive medications at randomization was recorded and appeared to be balanced across all randomized groups.
Treatment and follow-up for an average of 4 years are planned.
Clinical follow-up will concentrate on detection of potential side effects related to drug use and appropriate dose adjustments, assessment of adherence, and detection and verification of clinical events.
Replicate ultrasound examinations were performed at baseline. One ultrasound exam will be scheduled at follow-up at 1.5 to 2.5 years after randomization, and replicate
Ultrasound studies will be obtained at the end of the study.
The SECURE substudy will further quantify the magnitude and mechanisms of benefit for ACE inhibition and antioxidant therapy in atherosclerotic disease.
1. Am J Cardiol 1996;78:914-19. Study design
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Coronary Artery Disease, Interventions and Vascular Medicine
Keywords: Intermittent Claudication, Coronary Artery Disease, Stroke, Vitamin E, Follow-Up Studies, Blood Pressure, Risk Factors, Angioplasty, Ramipril, Peripheral Vascular Diseases, Informed Consent, Coronary Artery Bypass, Diabetes Mellitus
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