Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

April 17, 2009 updated by: Sanofi

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20506

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office
  • Australia
      • Macquarie Park, Australia
        • sanofi-aventis Australia & New Zealand administrative office
  • Austria
      • Vienna, Austria
        • Sanofi-Aventis Administrative Office
  • Belarus
      • Minsk, Belarus
        • Sanofi-Aventis Administrative Office
  • Belgium
      • Diegem, Belgium
        • Sanofi-Aventis Administrative Office
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office
  • Bulgaria
      • Sofia, Bulgaria
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Administrative Office
  • China
      • Shangaï, China
        • Sanofi-Aventis Administrative Office
  • Croatia
      • Zagreb, Croatia
        • Sanofi-Aventis Administrative Office
  • Denmark
      • Horsholm, Denmark
        • Sanofi-Aventis Administrative Office
  • Estonia
      • Tallinn, Estonia
        • Sanofi-Aventis Administrative Office
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi- Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Greece
      • Athens, Greece
        • Sanofi-Aventis Administrative Office
  • Hong Kong
      • Causeway Bay, Hong Kong
        • Sanofi-Aventis Administrative Office
  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis Administrative Office
  • India
      • Mumbai, India
        • Sanofi-Aventis Administrative Office
  • Ireland
      • Dublin, Ireland
        • Sanofi-Aventis Administrative Office
  • Israel
      • Natanya, Israel
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Jordan
      • Amman, Jordan
        • Sanofi-Aventis Administrative Office
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Sanofi-Aventis Administrative Office
  • Latvia
      • Riga, Latvia
        • Sanofi-Aventis Administrative Office
  • Lebanon
      • Beirut, Lebanon
        • Sanofi-Aventis Administrative Office
  • Lithuania
      • Vilnius, Lithuania
        • Sanofi-Aventis Administrative Office
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Norway
      • Lysaker, Norway
        • Sanofi-Aventis Administrative Office
  • Poland
      • Warszawa, Poland
        • Sanofi-Aventis Administrative Office
  • Portugal
      • Porto Salvo, Portugal
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis Administrative Office
  • Singapore
      • Singapore, Singapore
        • Sanofi-Aventis Administrative Office
  • Slovakia
      • Bratislava, Slovakia
        • Sanofi-Aventis Administrative Office
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • Sweden
      • Bromma, Sweden
        • Sanofi-Aventis Administrative Office
  • Switzerland
      • Geneva, Switzerland
        • Sanofi-Aventis Administrative Office
  • Thailand
      • Bangkok, Thailand
        • Sanofi-Aventis Administrative Office
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis Administrative Office
  • Ukraine
      • Kiev, Ukraine
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford Surrey, United Kingdom
        • Sanofi-aventis adminsitrative office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807-0890
        • Sanofi-Aventis Administrative Office
  • Uruguay
      • Montevideo, Uruguay
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Composite of all-cause mortality and non-fatal myocardial re-infarction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFC6147
  • XRP4563B/3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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