Interventional Cardiology and
Angiology

An Evaluation of Equivalence of Conservative
Versus Early Interventional Revascularization for Unstable Angina -
SPREE
- Aims: To determine the risks and the benefits of early
invasive diagnosis and early intervention in comparison to
conser-vative strategy.
- To evaluate the additional effect of a long lasting
"cooling-off" strategy on the incidence of major adverse cardiac
events.
- Design: Prospective, randomized multicenter clinical trial.
The initial phase of the study is designed as a pilot feasibility
trial with 200 patients. An independent data and safty monitoring
board will review all data. According to prospectively defined
stopping rules (see below) the sample size per group will be
increased on the basis of the event rate at the interim efficacy
analysis.
- The study includes one subgroup randomization procedure in the
conservative group.
Universitätsklinikum Charité - Medizinische Fakultät
der Humboldt-Universität zu Berlin, Campus Berlin-Buch
Franz-Volhard-Klinik
Wiltbergstraße 50, D - 13125 Berlin
Tel.: +49 30 9417 2996 - Fax: +49 30 9497 074
Letzte Änderung: 17.11.98 -
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