The total ischemic burden European trial (TIBET): design, methodology, and management. The TIBET Study Group.

TIBET is a European multicenter, double-blind parallel group trial with the main objective of investigating whether total ischemic burden has important prognostic implications in patients with stable angina on treatment. A secondary objective is to compare the antianginal and antiischemic effects of atenolol (50 mg bid), nifedipine (20-40 mg bid), and their combination using standardized exercise testing and Holter monitoring techniques. The main primary end points are cardiovascular morbidity and mortality. The secondary end points are time to onset of significant ischemia, angina on exercise stress testing, exercise capacity at onset of angina, 1-mm ST-segment depression and termination of exercise, total duration and number of significant ischemic episodes during 48 hours of Holter monitoring, and their circadian distribution. The target population, the assessments, and the management of the trial are described in detail.

RCT Entities:   Population Interventions Outcomes