Completed

A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy

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What is being tested

Data Collection

Who is being recruted

Cardiovascular Diseases
+6

+ Heart Diseases
+ Infarction
Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: October 2002
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2002Actual date on which the first participant was enrolled.

The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

Official TitleA Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy 
NCT00077792
Principal SponsorSanofi
Last updated: January 14, 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
20506 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
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

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.
Conditions
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.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Infarction
Ischemia
Myocardial Infarction
Necrosis
Pathologic Processes
Vascular Diseases
Myocardial Ischemia
Criteria

INCLUSION CRITERIA: Patients with ST-segment elevation acute myocardial infarction meeting all of the following criteria: * Male or non-pregnant female greater than or equal to 18 years of age (depending on local regulations, minimal age can vary between 18 and 21 years) * Onset of prolonged (greater than or equal to 20 min) ischemic symptoms at rest less than or equal to 6 hours prior to randomization * ST-segment elevation of 0.1 mV in 2 or more limb leads, or 0.2 mV in two (2) or more contiguous precordial leads, or left bundle-branch block * Planned reperfusion therapy with streptokinase, tenecteplase, alteplase or reteplase * Written informed consent will be obtained EXCLUSION CRITERIA: Cardiovascular * Evidence of cardiogenic shock at randomization * Acute pericarditis * History or symptoms suggestive of aortic dissection * MI precipitated by obvious provoking factors such as arrhythmia, infection, severe anemia, hyperthyroidism, cocaine, or amphetamine Hemorrhagic Risk * Any minor head trauma or any other trauma occurring after the index acute myocardial infarction * Active or recent (\< 3 months) bleeding including gastrointestinal bleeding, known presence of occult blood in the stool, or gross hematuria. * Any history of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia * Any single reliable recording of systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg prior to randomization * Any history of stroke or transient ischemic attack; any history of hemorrhagic cerebrovascular disease * Any known structural damage or other pathologic process involving the central nervous system * Any head trauma within 6 months prior to randomization * Major surgery (including CABG), any ophthalmologic surgery, or non-cutaneous biopsy, or substantial trauma within 3 months prior to randomization * Traumatic or prolonged cardiopulmonary resuscitation (\> 2 minutes) within 2 weeks prior to randomization * Puncture of a non-compressible vessel (artery or vein) within the 24 hours prior to randomization * Acute peptic ulcer disease within 3 months prior to randomization Prior or Concomitant Pharmacologic Therapy * Administration of abciximab (ReoPro), within the previous 7 days or eptifibatide (Integrilin), or tirofiban (Aggrastat) within the previous 24 hours prior to randomization * Current therapy with oral anticoagulants, or an International Normalized Ratio of \>1.5 * Administration of a low molecular weight heparin within 8 hours prior to randomization. * Known hypersensitivity to low molecular weight heparins, unfractionated heparin or heparin-like products; allergy to pork or pork products * Known hypersensitivity and/or contra-indication(s) to fibrinolytic drugs (streptokinase, tenecteplase, alteplase and reteplase) General * Known platelet count \<100,000 cells/microL or history of heparin-induced thrombocytopenia * Known clinically significant anemia (Hemoglobin \<10 g/dL which is \< 6.2 mmol/L) * Known renal insufficiency with serum creatinine \>220 mmol/L (2.5 mg/dL) for men and \>175 mmol/L (2.0 mg/dL) for women when assessed prior to baseline examination. * Advanced neoplastic or other life-threatening disease with a life expectancy of \<12 months * Pregnancy or parturition within the last 90 days or currently breast feeding * Women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having a negative pregnancy test. * Treatment with other investigational agents in the last 30 days before study entry or previous enrollment in ExTRACT-TIMI 25 * History of drug or alcohol abuse * Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study * Any patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and who are unlikely to complete the study

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 48 locations
Suspended
Sanofi-Aventis Administrative OfficeBridgewater, United StatesSee the location
Suspended
sanofi-aventis administrative OfficeBuenos Aires, Argentina
Suspended
sanofi-aventis Australia & New Zealand administrative officeMacquarie Park, Australia
Suspended
Sanofi-Aventis Administrative OfficeVienna, Austria
Completed48 Study Centers