Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 732
Mean Follow Up: Planned 4 years
Mean Patient Age: 65.4
Female: 23.8

Patient Populations:

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.

Primary Endpoints:

Atherosclerosis progression as assessed by quantitative carotid B-mode ultrasound

Secondary Endpoints:

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.

Drug/Procedures Used:

Ramipril 2.5mg daily, Ramipril 10mg daily, and vitamin E 400 IU daily using a factorial 3 X 2 study design.

Concomitant Medications:

Use of all cardioactive medications at randomization was recorded and appeared to be balanced across all randomized groups.