PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)

Completed

Phase 4 Results

Trial Description

Primary objective:
- To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke.
Secondary objectives:
- To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization
- To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization
- To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients were randomized to receive enoxaparin daily 40 mg SC or UFH 5000 IU SC Q 12 treatment for 10 days +/- 4 days with a follow up period of 90 days and stratified by NIH Stroke Scale Score (severe greater than or equal to 14 and less severe <14).

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite of symptomatic or asymptomatic deep-vein thrombosis (DVT), and/or symptomatic or fatal pulmonary embolism (PE) during the treatment period. Primary safety endpoints were symptomatic intracranial bleeding, major extracranial bleeding and all-cause mortality.
Secondary Incidence of VTE, incidence of stroke recurrence, rate of stroke progression, patient functional status, safety of using enoxaparin compared to UFH.
Primary Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) 10 ± 4 days following acute ischemic stroke No
Secondary cumulative VTE events at 30-day, 60-day and 90-day No
Secondary stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores during treatment and follow-up periods No
Secondary Modified Rankin Scale (MRS) scores at 30-day and 90-day follow-up No
Secondary major & minor hemorrhages from the inform consent signed up to the end of the study No
Secondary Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality from the inform consent signed up to the end of the study No

Sponsors