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

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077792
• Other study ID #: EFC6147
• Secondary ID: XRP4563B/3001
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2004
• Last updated: April 17, 2009
• Start date: October 2002
• Est. completion date: December 2006

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 to receive fibrinolytic therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20506
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute ST-Segment Elevation
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Enoxaparin sodium (XRP4563)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Jordan,  Korea, Republic of,  Latvia,  Lebanon,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, López-Sendón JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality and non-fatal myocardial re-infarction
Secondary	Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke