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Percutaneous Coronary InterventionPhase 2/3NCT00077844

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

A Phase 2/3 study testing Enoxaparin sodium in people with Percutaneous Coronary Intervention, run by Sanofi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Percutaneous Coronary Intervention
What is being tested?
Enoxaparin sodium
How many people
3,532 participants
Where
No sites listed yet
Study dates
Jan 2004to Sep 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

About this study

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

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.

Being tested
Enoxaparin sodium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enoxaparin sodiumDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the composite of non-CABG major and minor bleeding

    Measured: up to H48 after index PCI

Secondary outcomes (1)

  1. success rate of achieving ACT target range

    Measured: at the beginning and end of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionSep 2005
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,532 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077844
Sponsor's protocol ID
XRP4563_4001
Other IDs
EudraCT #: 2004-003743-44
Status last verified
Jan 2011
First submitted
12 Feb 2004
Last updated
11 Jan 2011
Results posted
No

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. doi: 10.1056/NEJMoa052711.

    PubMed 16957147

  • 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.

    PubMed 18276619

  • 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.

    PubMed 20102875

  • 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.

    PubMed 19926048

  • 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.

    PubMed 19081408

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Enoxaparin sodium in people with Percutaneous Coronary Intervention, run by Sanofi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the composite of non-CABG major and minor bleeding (time frame: up to H48 after index PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077844, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.

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