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

Sanofi

Status and phase

Completed

Phase 3

Phase 2

Conditions

Percutaneous Coronary Intervention

Treatments

Drug: Enoxaparin sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00077844

XRP4563_4001

EudraCT #: 2004-003743-44

Details and patient eligibility

About

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.

Enrollment

3,532 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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