Myocardial InfarctionPhase 3NCT00077792
Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
A Phase 3 study testing Enoxaparin sodium (XRP4563) in people with Myocardial Infarction and Acute ST-Segment Elevation, run by Sanofi at 48 sites in 48 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute ST-Segment Elevation
- What is being tested?
- Enoxaparin sodium (XRP4563)
- How many people
- 20,506 participants
- Where
- 48 sitesin 48 countries
- Study dates
- Oct 2002to Dec 2006
- Phase
- Phase 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
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
48 sites in 48 countries.
48 sites in 48 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807-0890
Australia1 site
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park
United Kingdom1 site
Sanofi-aventis adminsitrative office
Guildford Surrey
About this study
Official title: 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
- Conditions
- Myocardial Infarction, Acute ST-Segment Elevation
- Being tested
- Enoxaparin sodium (XRP4563)
- Keywords
- Receiving fibrinolytic therapy
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin sodium (XRP4563)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality and non-fatal myocardial re-infarction
Secondary outcomes (1)
Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startOct 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077792
- Sponsor's protocol ID
- EFC6147
- Other IDs
- XRP4563B/3001
- Status last verified
- Apr 2009
- First submitted
- 12 Feb 2004
- Last updated
- 20 Apr 2009
- Results posted
- No
Publications
Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, Lopez-Sendon JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006 Apr 6;354(14):1477-88. doi: 10.1056/NEJMoa060898. Epub 2006 Mar 14.
PubMed 16537665Morrow DA, Antman EM, Fox KA, White HD, Giugliano R, Murphy SA, McCabe CH, Braunwald E; ExTRACT-TIMI 25 Investigators. One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial. Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.
PubMed 20400762
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00077792
- Acronym / sponsor ID
- EFC6147
- Conditions
- Myocardial Infarction, Acute ST-Segment Elevation
- Keywords
- Receiving fibrinolytic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,506 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin sodium (XRP4563) | Drug | – |
Primary outcome
Composite of all-cause mortality and non-fatal myocardial re-infarction
1 secondary outcome
Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
- Results publication: PubMed 16537665Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, Lopez-Sendon JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006 Apr 6;354(14):1477-88. doi: 10.1056/NEJMoa060898. Epub 2006 Mar 14.
- Derived from this study: PubMed 20400762Morrow DA, Antman EM, Fox KA, White HD, Giugliano R, Murphy SA, McCabe CH, Braunwald E; ExTRACT-TIMI 25 Investigators. One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial. Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
48 sites in 48 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin sodium (XRP4563) in people with Myocardial Infarction and Acute ST-Segment Elevation, run by Sanofi at 48 sites in 48 countries.
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 6 inclusion and 34 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 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Argentina, Australia, Austria, Belarus and 43 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Composite of all-cause mortality and non-fatal myocardial re-infarction. 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 NCT00077792, which also lists 2 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 20 Apr 2009; AzTrials last refreshed its copy on 8 Nov 2026.