Study to Evaluate Carotid Ultrasound changes in patients treated with Ramipril and vitamin E "SECURE"

Completed

Phase N/A Results

Trial Description

To investigate the effects of an ACE inhibitor (ramipril) and vitamin E on atherosclerotic progression in high-risk patients.

Interventions

  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials
  • Vitamins Drug
    Intervention Desc: Attempt to lower homocysteine by vitamin therapy (folate, B6, B12).

Trial Design

A substudy of the HOPE trial, this was a prospective, double-blind, 3 X 2 factorial trial.

Patient Involvement

All patients were given ramipril 2.5 mg/day for 7-10 days, had their creatinine and potassium measured, were given placebo for 10-14 days, and had their creatinine and potassium measured again. Any patients who were unable to tolerate the study medications were removed from the trial at this time. Remaining patients were randomly assigned to receive placebo, ramipril 2.5 mg/day or ramipril 10 mg/day, and placebo or vitamin E 400 IU/day. Follow-up visits occurred at 1 month, and every 6 months thereafter. Blood pressure was recorded at randomization, 1 month, 2 years, and at the end of the study (4.5 years). CUS was performed in duplicate (maximum 3 weeks apart), once at randomization and once at the end of the study.

Outcomes

Type Measure Time Frame Safety Issue
Primary Atherosclerotic progression, as defined by the annualized progression slope of the mean maximum carotid intimal-medial thickness (IMT) across 12 pre-selected carotid segments.
Secondary Annualized progression slopes of the IMT's across any one of the 12 carotid segments.

Sponsors

Medical Research Council of Canada, Hoechst-Marion Roussel