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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00077792




Registration number
NCT00077792
Ethics application status
Date submitted
12/02/2004
Date registered
16/02/2004
Date last updated
20/04/2009

Titles & IDs
Public title
Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)
Scientific 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
Secondary ID [1] 0 0
XRP4563B/3001
Secondary ID [2] 0 0
EFC6147
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Acute ST-Segment Elevation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin sodium (XRP4563)

Treatment: Drugs: Enoxaparin sodium (XRP4563)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of all-cause mortality and non-fatal myocardial re-infarction
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Composite of all-cause mortality, non-fatal myocardial re-infarction, and myocardial ischemia leading to urgent revascularization and non-fatal disabling stroke
Timepoint [1] 0 0

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
20506
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belarus
State/province [4] 0 0
Minsk
Country [5] 0 0
Belgium
State/province [5] 0 0
Diegem
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Canada
State/province [8] 0 0
Laval
Country [9] 0 0
Chile
State/province [9] 0 0
Santiago
Country [10] 0 0
China
State/province [10] 0 0
Shangaï
Country [11] 0 0
Croatia
State/province [11] 0 0
Zagreb
Country [12] 0 0
Denmark
State/province [12] 0 0
Horsholm
Country [13] 0 0
Estonia
State/province [13] 0 0
Tallinn
Country [14] 0 0
Finland
State/province [14] 0 0
Helsinki
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Greece
State/province [17] 0 0
Athens
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Causeway Bay
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
India
State/province [20] 0 0
Mumbai
Country [21] 0 0
Ireland
State/province [21] 0 0
Dublin
Country [22] 0 0
Israel
State/province [22] 0 0
Natanya
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Jordan
State/province [24] 0 0
Amman
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
Latvia
State/province [26] 0 0
Riga
Country [27] 0 0
Lebanon
State/province [27] 0 0
Beirut
Country [28] 0 0
Lithuania
State/province [28] 0 0
Vilnius
Country [29] 0 0
Malaysia
State/province [29] 0 0
Kuala Lumpur
Country [30] 0 0
Mexico
State/province [30] 0 0
Mexico
Country [31] 0 0
Netherlands
State/province [31] 0 0
Gouda
Country [32] 0 0
Norway
State/province [32] 0 0
Lysaker
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Portugal
State/province [34] 0 0
Porto Salvo
Country [35] 0 0
Romania
State/province [35] 0 0
Bucuresti
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Moscow
Country [37] 0 0
Singapore
State/province [37] 0 0
Singapore
Country [38] 0 0
Slovakia
State/province [38] 0 0
Bratislava
Country [39] 0 0
South Africa
State/province [39] 0 0
Midrand
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Sweden
State/province [41] 0 0
Bromma
Country [42] 0 0
Switzerland
State/province [42] 0 0
Geneva
Country [43] 0 0
Thailand
State/province [43] 0 0
Bangkok
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Ukraine
State/province [45] 0 0
Kiev
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Guildford Surrey
Country [47] 0 0
Uruguay
State/province [47] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00077792
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00077792