Background: Small sample size and methodologic limitations make it difficult to interpret and
compare trials of low molecular—weight heparin (for example, enoxaparin) versus unfractionated
heparin as prophylactic treatment for venous thromboembolism (VTE), that is, deep
vein thrombosis and/or pulmonary embolism, in patients with acute ischemic stroke.
This prospective, open-label, randomized, parallel-group, multicenter trial is designed
to evaluate the efficacy and safety of enoxaparin versus unfractionated heparin for
the prevention of VTE after acute ischemic stroke. Methods: Approximately 1760 patients with the diagnosis of acute ischemic stroke accompanied
by leg paralysis will be randomly assigned (1:1) within 48 hours of stroke symptoms
to receive enoxaparin (40 mg subcutaneously) once daily or unfractionated heparin
(5000 U subcutaneously) every 12 hours for 10 ± 4 days. Contrast venography will be
used to evaluate asymptomatic patients after treatment for deep vein thrombosis. In
addition, diagnostic algorithms will be used to objectively confirm or rule out VTE
events for patients in whom upper- or lower-extremity deep vein thrombosis/pulmonary
embolism is suggested. Results: The primary efficacy end point measure will be the cumulative occurrence of documented
VTE during the initial treatment period. Secondary end points are VTE incidence; neurologic
outcome at days 30, 60, and 90; safety; and health care resource use during initial
hospitalization and during the 30- and 90-day follow-up periods. Conclusions: This study will provide clinical and health economic data regarding the use of enoxaparin
as primary prophylactic treatment of VTE in patients who have had an acute ischemic
stroke.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Journal of Stroke and Cerebrovascular DiseasesAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- The greater Cincinnati/Northern Kentucky stroke study.Stroke. 1998; 29: 415-421
- Incidence and occurrence of total (first-ever and recurrent) stroke.Stroke. 1999; 30: 2523-2528
- Medical and neurological complications of ischemic stroke.Stroke. 1998; 29: 447-453
- Prophylaxis of venous thromboembolism in stroke patients.Semin Thromb Hemost. 1997; 23: 155-157
- Low-dose subcutaneous heparin in the prevention of deep-vein thrombosis and pulmonary emboli following acute stroke.Age Ageing. 1986; 15: 84-88
- Prevention of venous thromboembolism.Chest. 2001; 119: 132S-175S
- Venous thromboembolism after acute stroke.Stroke. 2001; 32: 262-267
- A multicentre, double-blind, randomized study to compare the safety and efficacy of once-daily ORG 10172 and twice-daily low-dose heparin in preventing deep-vein thrombosis in patients with acute ischemic stroke.Age Ageing. 1994; 23: 512-516
- Enoxaparin, a low-molecular weight heparin is superior to heparin in the prevention of deep-vein thrombosis in stroke patients.Stroke. 1999; 29: 304
- A low-molecular-weight heparinoid compared with unfractionated heparin in the prevention of deep vein thrombosis in patients with acute ischemic stroke.Ann Intern Med. 1992; 117: 353-357
- Recent clinical trials in the diagnosis of deep-vein thrombosis.Curr Opin Hematol. 1999; 6: 275-279
- Diagnosis of venous thromboembolic disease in cancer patients.Oncology (Huntingt). 2003; 17 (139–144): 126-135
- Measurements of acute cerebral infarction.Stroke. 1989; 20: 864-870
- Recovery of motor function after stroke.Stroke. 1988; 19: 1497-1500
- Contrast venography, the gold standard for the diagnosis of deep-vein thrombosis.Thromb Haemost. 1992; 67: 8-12
- Roentgen diagnosis of venous thrombosis in the leg.Arch Surg. 1972; 104: 134-144
- The diagnostic approach to acute venous thromboembolism: Clinical practice guideline; American Thoracic Society.Am J Respir Crit Care Med. 1999; 160: 1043-1066
- Value of the ventilation perfusion scan in acute pulmonary embolism.JAMA. 1990; 263: 2753-2759
- Determining sample size and power in clinical trials.Semin Reprod Endocrinol. 1996; 14: 125-131
- The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results.Ann Intern Med. 1994; 121: 200-206
- Computations for group sequential boundaries using the Lan-DeMets spending function method.Control Clin Trials. 2000; 21: 190-207
- Use of spending functions for occasional or continuous monitoring of data in clinical trials.Stat Med. 1993; 12: 2219-2231
- Interim analyses and early termination of clinical trials.J Biopharm Stat. 1997; 7: 533-543
- Interim analyses with delayed observations in clinical trials.Stat Med. 1999; 18: 1297-1306
- Stroke recovery profile and the modified Rankin assessment.Neuroepidemiology. 2001; 20: 26-30
- Tissue plasminogen activator for acute ischemic stroke.N Engl J Med. 1995; 333: 1581-1587
- Low-molecular-weight heparins and heparinoids in acute ischemic stroke.Stroke. 2000; 31: 1770-1778
- Antithrombotic and thrombolytic therapy for ischemic stroke.Chest. 2001; 119: 300S-320S
- Low-dose heparin as a prophylaxis against deep-vein thrombosis after acute stroke.Lancet. 1977; 2: 800-801
- Double-blind randomized trial of ORG 10172 low-molecular-weight heparinoid in prevention of deep-vein thrombosis in thrombotic stroke.Lancet. 1987; 1: 523-526
- Prophylaxis of deep venous thrombosis with a low-molecular-weight heparin (Kabi 2165/Fragmin) in stroke patients.Haemostasis. 1989; 19: 245-250
- A double-blind and randomized placebo-controlled trial of low molecular weight heparin once daily to prevent deep-vein thrombosis in acute ischemic stroke.Semin Thromb Hemost. 1990; 16: 25-33
- Low-molecular weight heparins in venous and arterial thrombotic disease.Thromb Haemost. 1999; 82: 139-147
- Low-molecular-weight heparins or heparinoids versus standard unfractionated heparin for acute ischaemic stroke.Cochrane Database Syst Rev. 2001; 4 (CD000119)
- Design considerations in stroke clinical trials.in: Grotta J. Miller L.P. Buchan A.M. Ischemic stroke Recent advances in understanding and therapy. International Business Communications Inc, Southborough1995: 2-29
Article info
Publication history
Accepted:
December 20,
2004
Received:
September 10,
2004
Footnotes
Supported by Aventis.
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2004.12.008
Copyright
© 2005 National Stroke Association. Published by Elsevier Inc. All rights reserved.
