Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00077844

Purpose

The purpose of this study is to evaluate the efficacy and safety of intravenous enoxaparin versus intravenous unfractionated heparin (UFH) in patients undergoing non-emergent PCI, as assessed by measuring the incidence of non-coronary artery bypass graft (CABG) major and minor bleeding.

Condition	Intervention	Phase
Percutaneous Coronary Intervention	Drug: Enoxaparin sodium	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	An International Phase 2-3, Stratified, Randomized, Open-label, Parallel-group Clinical Trial to Evaluate the Safety and Efficacy of a Single Intravenous Bolus of Enoxaparin Versus Intravenous Unfractionated Heparin in Patients Undergoing Non-emergent Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Enoxaparin Sodium Heparin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

the composite of non-CABG major and minor bleeding [ Time Frame: up to H48 after index PCI ]

Secondary Outcome Measures:

success rate of achieving ACT target range [ Time Frame: at the beginning and end of procedure ]

Estimated Enrollment:	3532
Study Start Date:	January 2004
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA

Male or non-pregnant female greater than or equal to 18 years of age
Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure
PCI to be performed with a femoral approach

EXCLUSION CRITERIA

Known or suspected pregnancy in women of childbearing potential
Thrombolytic therapy within the previous 24 hours
Undergoing primary PCI for ongoing ST-segment elevation myocardial infarction (STEMI)
Undergoing rescue PCI after failed thrombolysis
Any other elective PCI scheduled within the following 30 days after the index PCI
Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intracranial tumor or aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding
Uncontrolled arterial hypertension
Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
Impaired haemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL)
History of hypersensitivity or contraindication to heparin or LMWH
Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for vitamin-K antagonist therapy
Treatment with a direct thrombin inhibitor, low molecular weight heparin, or unfractionated heparin within the 24 hours preceding enrolment
Use of abciximab within the previous 7 days or, tirofiban, or eptifibatide within the past 12 hours of index PCI
Inability to give informed consent or high likelihood of being unavailable for follow-up
Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077844

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Luc Sagnard

Sanofi-Aventis

More Information

Publications:

Montalescot G, White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB 3rd, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR; STEEPLE Investigators. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med. 2006 Sep 7;355(10):1006-17.

Montalescot G, Cohen M, Salette G, Desmet WJ, Macaya C, Aylward PE, Steg PG, White HD, Gallo R, Steinhubl SR; STEEPLE Investigators. Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial. Eur Heart J. 2008 Feb;29(4):462-71.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

White HD, Aylward PE, Gallo R, Bode C, Steg G, Steinhubl SR, Montalescot G; STEEPLE Investigators. Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial. Am Heart J. 2010 Jan;159(1):110-6.

Montalescot G, Gallo R, White HD, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB 3rd, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR; STEEPLE Investigators. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention 1-year results from the STEEPLE (SafeTy and efficacy of enoxaparin in percutaneous coronary intervention patients, an international randomized evaluation) trial. JACC Cardiovasc Interv. 2009 Nov;2(11):1083-91.

White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Steinhubl S, Montalescot G. The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial. Am Heart J. 2009 Jan;157(1):125-31. Epub 2008 Nov 12.

ClinicalTrials.gov Identifier:	NCT00077844 History of Changes
Other Study ID Numbers:	XRP4563_4001, EudraCT #: 2004-003743-44
Study First Received:	February 12, 2004
Last Updated:	January 10, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012