Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial.
Int J Stroke
; : 17474930211041213, 2021 Aug 29.
Article
in En
| MEDLINE
| ID: mdl-34427481
ABSTRACT
RATIONALE Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment, but the optimal target of BP management remains uncertain. AIM:
We hypothesized that the clinical outcome after intensive BP-lowering is superior to conventional BP control after successful recanalization by intra-arterial treatment. SAMPLE-SIZE ESTIMATES We aim to randomize 668 patients (334 per arm), 11. METHODS ANDDESIGN:
We initiated a multicenter, prospective, randomized, open-label trial with a blinded end-point assessment (PROBE) design. After successful recanalization (thrombolysis in cerebral infarction score ≥ 2 b), patients with elevated systolic BP level, deï¬ned as the mean of two readings ≥ 140 mmHg, will be randomly assigned to the intensive BP-lowering (systolic BP < 140 mm Hg) group or the conventional BP-lowering (systolic BP, 140-180 mm Hg) group. STUDYOUTCOMES:
The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at three months (mRS scores 0-2 vs. 3-6). The primary safety outcomes are symptomatic intracerebral hemorrhage and death within three months.DISCUSSION:
The OPTIMAL-BP trial will provide evidence for the effectiveness of active BP control to achieve systolic BP < 140 mmHg during 24 h in patients with successful recanalization after intra-arterial treatment. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04205305.
Full text:
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Database:
MEDLINE
Type of study:
Clinical_trials
/
Prognostic_studies
Language:
En
Year:
2021
Type:
Article