Intensive blood-pressure control for the prevention of major cardiovascular events in stroke patients: rationale and design of the OPTIMAL-STROKE trial.
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Silva Gisele S, Machline-Carrion M J, Santo Karla, Clares de Andrade João B, Martins Eduardo, Guimarães Patrícia, Monfardini Frederico, Nieri Josué, Assis Silvia R L, Martins Sheila Cristina O, Pontes Neto Octávio M, Feitosa Audes D M, Moro Carla H C, Fuchs Sandra C, Gagliardi Rubens, Silvestre Odilson, Pereira Silva Ricardo, Antunes Murillo, Alves Maramélia M, Minelli Cesar, Maia Lilia N, Bortolotto Luiz A, Sousa Marcio G, Drager Luciano F, Bazan Rodrigo, Vilela-Martin José F, Oliveira-Filho Jamary, Zetola Viviane, Avelar Wagner, Carbonera Leonardo A, Braga Gabriel P, Conforto Adriana B, Tavares Caio A M, Lima Fabrício O, Martins Gladys L, Rebello Letícia Costa, Rodgers Anthony, Whelton Paul K, Fuchs Flavio D, Berwanger Otavio
Аннотация
STUDY DESIGN: OPTIMAL-STROKE is a multicentre, randomised, controlled, open-label clinical trial with blinded and independent assessment of clinical outcomes and intention-to-treat primary analysis. Patients with a history of IS or TIA and high BP (SBP of 130-180 mmHg), clinically stable for at least 48 h prior to trial inclusion, are centrally randomised with concealed allocation in a 1:1 ratio to either an intensive BP control strategy targeting a SBP < 120 mmHg or a standard control strategy targeting a SBP < 140 mmHg. A total of 495 primary outcome events, 4368 patients enrolled.
STUDY ENDPOINTS: The primary outcome is the first occurrence of a composite outcome of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalisation for unstable angina or hospitalisation for heart failure).
SUMMARY: OPTIMAL-STROKE will be the first adequately powered trial of intensive BP control in the prevention of major cardiovascular events in patients with a history of IS or TIA.
TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT04036409).