A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II)

Terminated

Phase 3 Results N/A

Trial Description

The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.

Detailed Description

Abciximab is a drug that prevents platelets from sticking together and forming a clot. There are limited studies using abciximab in the treatment of strokes. This phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study is designed to assess the effectiveness and safety of abciximab for treatment of acute ischemic stroke, in helping dissolve clots in brain arteries so that blood and oxygen can flow better and there may be less brain damage.
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either Abciximab: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 µg/kg/min infusion (to a maximum of 10 µg/min) for 12 hours or a bolus of placebo followed by infusion for 12 hours

Trial Stopped: Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to receive either abciximab or placebo given as a bolus (0.25 mg/kg), followed by 12 hours infusion (0.125 µg/kg/min, 10µg/min maximum).

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional outcome measured by the modified Rankin Scale (mRS) responder analysis at 3 months in patients treated within 5 hours of stroke onset. Responders are patients with a baselin NIHSS of 4-7 must achieve an mRS of 0, and those with baseline of NIHSS of 8-14 must achieve = 1. The most severe patients (NIHSS 15-22) must achieve mRS = 2.
Secondary Proportion of patients with neurological recovery (NIHSS 0 - 1) at 3 months and all-causes of mortality during the first 3 months in patients enrolled within 5 hours.
Primary The proportion of modified Rankin Scale responders at 3 months in the primary population.
Secondary Proportion of patients with neurological recovery and all-cause mortality at 3 months in the primary population. Fatal intracranial-, nonfatal symptomatic parenchymal-, or other symptomatic intracranial hemorrhages though discharge at day 5 & 3 months

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