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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00077844

Enrollment

3532

Registered

2004-02-18

Start date

2004-01-31

Completion date

2005-09-30

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention

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.

Interventions

DRUGEnoxaparin sodium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the composite of non-CABG major and minor bleeding	up to H48 after index PCI

Secondary

Measure	Time frame
success rate of achieving ACT target range	at the beginning and end of procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026