Clinical trial NCT00077844: Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI) Patients, an International Randomized Evaluation (STEEPLE)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-02-18
Enrollment: 3532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: the composite of non-CABG major and minor bleeding
timeFrame: up to H48 after index PCI
Secondary outcomes:
measure: success rate of achieving ACT target range
timeFrame: at the beginning and end of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Luc Sagnard
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1056/NEJMoa052711.
citation: 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. doi: 10.1093/eurheartj/ehn008.
citation: 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. doi: 10.1016/j.ahj.2009.10.034.
citation: 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. doi: 10.1016/j.jcin.2009.08.016.
citation: 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. doi: 10.1016/j.ahj.2008.08.019. Epub 2008 Nov 12.