Completed

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

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What is being tested

Data Collection

Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2 & 3
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleAn 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 
NCT00077844
Principal SponsorSanofi
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
3532 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers
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