Blood Pressure Control in Acute Ischemic Stroke
Condition: Blood Pressure; Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Management of acutely elevated blood pressure during the early phase of ischemic stroke
      remains controversial. In patients treated with IV-tPA, the risk of ICH is closely related to
      the BP levels. However, intensive reduction of BP carries a theoretical risk of clinical
      deterioration by inducing cerebral hypoperfusion. Assessment of cerebral perfusion before and
      after BP reduction is one of the most scientific method to evaluate the safety (and potential
      benefits) of BP management in the acute phase of stroke. This project will impact practices
      and delivery of BP management during the acute phase of ischemic stroke. The findings would
      aid in designing phase 3 clinical trials will track clinical indicators, including the impact
      on functional outcomes as well as quality-of-life and cost-effectiveness.
    

Detailed description: 
      Specific aims-

        1. 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,

        2. To quantify the effect of intensive BP lowering on cerebral blood flow (CBF) as measured
           by computed tomographic (CT) perfusion imaging.

        3. 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.
    

Intervention name(s): Early intensive BP control
Intervention type(s): Biological
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stroke; blood pressure; hemodynamic