Controlling Hypertension and Hypotension Immediately Post-Stroke Trial "CHHIPS"

Completed

Phase N/A Results

Trial Description

To determine the extent to which blood pressure should be managed in the acute stroke setting.

Interventions

  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials

Trial Design

Prospective, multi-centre, randomized, double-blind, placebo-controlled, titrated-dose trial.

Patient Involvement

All routine aspects of management of patients will be continued as standard local practice. The following specific interventions will be given to individual groups: (1) intravenous (iv) phenylephrine at 80?g/min or matching placebo (PLA), titrated to target SBP 150mmHg (range 145 to 155) or 15mmHg increase above baseline, and continued until maximum period 24 hrs after stroke onset; (2) oral lisinopril (LIS) 5mg or LAB 50mg or matching PLA, repeated if necessary at 4 and 8 hrs after initial dosing to target SBP 150mmHg (145 to 155) or 15mmHg reduction from baseline, and continued at dose of LIS 5 to 15mg daily or LAB 50 to 150mg twice daily or matching PLA until 2 wks after stroke onset; (3) sublingual (sl) LIS 5mg and iv PLA or sl PLA and iv LAB 50mg or sl and iv PLA, adjusted if necessary at 4 and 8 hours after initial dosing to target SBP 150mmHg (145 to 155) or 15mmHg reduction from baseline, and continued at dose of LIS 5 to 15 mg daily or LAB 50 to 150 mg twice daily or PLA until 72 to 96 hours after stroke onset, thereafter as LIS, LAB or PLA suspension by nasogastric tube (in patients remaining non-dysphagic) or orally (in patients regaining swallow) until 2 weeks after stroke onset.

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary outcome will be proportion of patients dead or dependent (mRS >3) at 14 days following stroke onset.
Secondary Secondary outcomes will include early (<72 hours) neurological deterioration, stroke recurrence over 2 weeks, treatment discontinuations, trial withdrawals, BP changes at 24 hrs and 2 wks, and health-related quality of life at 3 months.

Sponsors

National Health Service Health Technology Assessment Program