Blood Pressure Control in Acute Ischemic Stroke (BP-Stroke)
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|ClinicalTrials.gov Identifier: NCT03443596|
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Acute Stroke||Biological: Early intensive BP control||Phase 2 Phase 3|
- To determine the tolerability of intensive blood pressure (BP) lowering with intravenous Labetalol infusion (assessed by achieving systolic BP 140-160mmHg range within 6hours of symptom-onset and maintaining it for 72hours post-ictus) in subjects with acute ischemic stroke (AIS) who are treated with intravenous thrombolysis,
- To quantify the effect of intensive BP lowering on cerebral blood flow (CBF) as measured by computed tomographic (CT) perfusion imaging.
- To obtain preliminary estimates of clinical impact of intensive BP lowering in acute phase and functional outcomes at 3months.
Hypothesis- Investigators hypothesize that early and intensive BP lowering in AIS is safe in patients treated with intravenous tissue plasminogen activator (IV-TPA). Furthermore, such reductions in BP would not produce any significant reduction of CBF on CT perfusion or adversely affect the functional outcomes at 3 months
Methodology - AIS patients presenting within 4.5hours of symptom-onset with measurable neurological deficits (NIHSS >4points), treated with intravenous thrombolysis and having elevated BP (systolic BP 160-185mmHg) would be included. In this randomised open label pilot study (with blinded end-point analysis), study participants in target group would receive intravenous Labetalol infusion for 72hours (target systolic BP 140-160mmHg).Close neurological monitoring and serial CT perfusion studies would be performed to evaluate the short-term clinical effects and changes in CBF. Functional outcomes would be evaluated by modified Rankin scale at 3months.
Conclusion This pilot randomised study would provide preliminary data about the safety of intensive BP lowering in AIS and form a basis of designing a larger phase III study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled study|
|Masking Description:||Allocation of the BP control arm was not disclosed to the study participants|
|Official Title:||A Randomised Clinical Trial for Evaluating the Safety and Feasibility of Intensive Lowering of Blood Pressure in Acute Ischemic Stroke Patients Treated With Intravenous Thrombolysis|
|Actual Study Start Date :||December 1, 2014|
|Actual Primary Completion Date :||March 13, 2019|
|Actual Study Completion Date :||March 13, 2019|
Active Comparator: Early intensive BP control
BP in participants in this arm is treated aggressively, lowered and maintained at systolic blood pressure between 140-160mmHg, within 6 hours of stroke onset and maintained in this range for first 72 hours.
Biological: Early intensive BP control
Participants in the early intensive BP control arm are treated with BP lowering medications, with an aim to bring the systolic BP to 140-160mmHg and maintain this level for 72 hours post-ictus
No Intervention: Guidelined based BP control
Participants are treated according to the current international guidelines in thrombolysed acute ischemic stroke patients, i.e., less than 180/105mmHg
- Increase in NIHSS during early intensive BP lowering [ Time Frame: within first 72 hours ]Proportion of subjects whose NIHSS increases by 4 or more points during active BP reduction.
- Good functional outcome [ Time Frame: at 90 days ]Proportion of subjects achieving modified Rankin score 0-1 in early intensive BP control as compared to the subjects treated with guideline based BP control
- Ccerebral blood flow reduction during BP control [ Time Frame: within first 72 hours ]Proportion of subjects whose cerebral blood flow on CT perfusion reduces by 20% or more during intensive BP lowering as compared to guideline based approach of BP management in acute ischemic stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443596
|Division of Neurology, National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Vijay K Sharma, MD||National University Health System, Singapore|