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Table summary of clinical trials for Enoxaparin back     pdf    short list

Clinical trials of Enoxaparin (enoxaparin, Lovenox, Clexane) are available for the clinical conditions:


DVT prophylaxis

These trials are included in meta-analysis concerning: LMWH in general surgery, antithrombotics in general surgery, heparin (UFH or LMWH) in general surgery, antithrombotics in orthopedic surgery, antithrombotics in medical patients, heparin (UFH or LMWH) in orthopedic surgery, LMWH in orthopedic surgery, antithrombotics in elective hip replacement, antithrombotics in neurosurgery, heparin (UFH or LMWH) in neurosurgery, LMWH in neurosurgery, LMWH in abdominal surgery, antithrombotics in abdominal surgery, antithrombotics in arthroscopy, LMWH in gynaecological surgery, antithrombotics in gynaecological surgery, antithrombotics in elective major knee surgery, antithrombotics in urologic surgery, UFH in urologic surgery,

enoxaparin vs control
Canata ,2003 enoxaparin sc daily (dose not specified)
versus
no treatment
ACL reconstruction for symptomatic ACL-deficient knees   Follow-up: 6 days

Italy 
enoxaparin vs no treatment
Warwick ,1995 enoxaparin 4000x1 + elastic stockings
versus
no treatment + elastic stockings
Elective hip  Follow-up: 8-10 days
open
 
Ho [43] Enoxaparin 4000 anti-Xa units
versus
No treatment
  Follow-up:
Open
 
enoxaparin vs placebo
Turpie ,1986 Enoxaparin 3000 x2
versus
Placebo
Elective hip  Follow-up: 14 days or discharge
double blind
 
Leclerc ,1991 Enoxaparin 3000 x2
versus
Placebo
Knee  Follow-up: 14 days
double blind
 
Samama ,1997 enoxaparin 4000x1+elastic stockings
versus
Placebo+elastic stockings
Elective hip  Follow-up: 8-12 days
double blind
 
Kalodiki ,1996 enoxaparin 4000x1
versus
Placebo
Elective hip  Follow-up: discharge (8-12 days )
double blind
 
Samama ,1999 Enoxaparin 20 mg or 40 mg once daily, 6–14 days
versus
placebo
Acute decompensated chronic obstructive pulmonary disease with mechanical ventilation  Follow-up: 6-14 days
double blind
 
Lederle ,2006 Enoxaparin 40 mg once daily, until hospital discharge
versus
placebo
Hospitalization in general medical unit  Follow-up: 90 days
double blind
 
LeGagneux ,1987 Enoxaparin 6000 anti-Xa units
versus
Placebo
prostatectomy surgery  Follow-up:
Blind
 
Agnelli ,1998 Enoxaparin, 40 mg/d subcutaneously within 24 hours postoperatively plus compression stockings for >=7 days
versus
compression stockings + placebo
Elective neurosurgery, 18 years or older, without excess bleeding risk   Follow-up: 30 days

 
Melon ,1987 Enoxaparin, 20 mg/d subcutaneously 18-24 hours postoperatively for 10 days
versus
placebo
Neurosurgery, adult, 45-90 kg of weight, without excess bleeding risk   Follow-up: NA

 
enoxaparin vs Dextran
DES Group ,1991 Enoxaparin
versus
Dextran
Elective hip  Follow-up:

 
out of hospital Enoxaparin vs standard prophylaxis
Bergqvist ,1996 in hospital thromboprophylaxis followed by out of hospital Enoxaparin 40 mg once a day for a total duration of 30 days
versus
Enoxaparin 40 mg once a day for 10-11 days
THR  Follow-up:

 
Planes ,1996 in hospital thromboprophylaxis followed by out of hospital Enoxaparin 40 mg once a day for a total duration of 35 days
versus
Enoxaparin 40 mg once a day for 13-15 days
THR  Follow-up:

 
Comp ,2001 in hospital thromboprophylaxis followed by out of hospital Enoxaparin 40 mg once a day for a total duration of 27-29 days
versus
Enoxaparin 30 mg twice a day for 7-10 days
THR or TKR  Follow-up:

 
enoxaparin vs UFH
Bergmann and Neuhart ,1996 enoxaparin 20 mg once daily for 10 days
versus
unfractionated heparin (UFH) 5000 IU twice daily
elderly in-patients bedridden for an acute medical illness  Follow-up: 10 days
double-blind
 
Lechler ,1996 enoxaparin 40 mg
versus
unfractionated heparin (Ca-heparin), 3 x 5,000 U)
hospitalized medical patients  Follow-up: 7 days
double-blind
 
Kleber ,2003 enoxaparin 40 mg once daily for 10 +/2 days
versus
UFH 5000 IU 3 times daily for 10 +/2 days
severe respiratory disease or heart failure  Follow-up: 10 +/- 2 days
open
Germany 
enoxaparin vs Unfractionated heparin
Planes ,1988 Enoxaparin
versus
Unfractionated heparin
Elective hip  Follow-up:

 
Levine ,1991 Enoxaparin
versus
Unfractionated heparin
Elective hip  Follow-up:

 
enoxaparin vs unfractionated heparin
Samama 1 ,1988 Enoxaparin 2000
versus
UFH 15 000 units
General surgery  Follow-up: 7 days
Open
 
Samama 2 ,1988 Enoxaparin 4000
versus
UFH 15 000 units
General surgery  Follow-up: 7 days
Open
 
Samama 3 ,1988 Enoxaparin 6000
versus
UFH 15 000 units
General surgery  Follow-up: 7 days
Open
 
Kaaja ,1992 Enoxaparin 2000 anti Xa units
versus
UFH 10 000 units
Gynaecological surgery  Follow-up:
Blind
 
Gazzaniga (ISG) ,1993 Enoxaparin 2000 anti Xa units
versus
UFH 10 000 units
General and vascular surgery  Follow-up:
Open
 
Nurmohamed ,1995 Enoxaparin 2000 anti Xa units
versus
UFH 15 000 units
General surgery  Follow-up:
Blind
 
McLeod (Canadian) ,1995 Enoxaparin 4000 anti Xa units
versus
UFH 15 000 units
Colorectal surgery  Follow-up:
Blind
 
Gonzalez ,1996 Bemiparin 2500 anti Xa units
versus
UFH 10 000 units
Abdominal surgery  Follow-up:
Blind
 
ENOXACAN ,1997 Enoxaparin 4000 anti Xa units
versus
UFH 15 000 units
Abdominopelvic surgery  Follow-up:
Blind
 

Percutaneous coronary intervention

These trials are included in meta-analysis concerning: antithrombotics in all type of patients, anticoagulant in all type of patients, antithrombotics in MI patients undergoing primary PCI, anticoagulant in patients undergoing primary PCI,

enoxaparin vs no control
FINESSE
versus
  Follow-up:

 
enoxaparin vs UFH
STEEPLE ,2006
NCT00077844
enoxaparin (0.5 or 0.75 mg per kilogram of body weight)
versus
unfractionated heparin (adjusted for activated clotting time)
elective percutaneous coronary intervention.  Follow-up:
open
 
Rabah ,1999 Enoxaparin 1 mg/kg bolus
versus
UFH 10,000 IU bolus, then titrated to ACT > 300
PCI for stable angina  Follow-up:
open
 
CRUISE ,2003 Enoxaparin 0.75 mg/kg bolus
versus
UFH 60 IU/kg bolus, then titrated to ACT > 200
Urgent or elective PCI  Follow-up: 2,7 +30 days
open
 
Galeote ,2001 Enoxaparin 0.75 mg/kg bolus
versus
UFH 70 U/kg bolus, then titrated to ACT > 200
PTCA patients with stable/unstable angina or AMI  Follow-up:

 
Dudek ,2000 Enoxaparin 1 mg/kg bolus
versus
UFH titrated to ACT > 300
PCI  Follow-up: 3à days

 
Dudek b (enox alone) ,2000 Enoxaparin 1 mg/kg bolus
versus
UFH titrated to ACT > 300
PTCA complex lesionsCI  Follow-up:

 
Drozd ,2001 Enoxaparin 1 mg/kg bolus
versus
UFH 100 IU/kg bolus
PCI for stable angina  Follow-up: 24hrs, 30 days

 
Dubek b (+abciximal) ,2001 Enoxaparin 0.75 mg/kg bolus + abciximab
versus
UFH titrated to ACT > 300
  Follow-up:

 
ATOLL ,2010 IV enoxaparin
versus
UFH
patients undergoing PCI for acute STEMI   Follow-up: 30 days
open
Austria, France, Germany, and US 
Brieger enoxaparin
versus
unfractionated heparin
patients undergoing percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)   Follow-up:

 
enoxaparin vs unfractionated heparin
STREAM (ongoing)
NCT00882635
Enoxaparin
versus
Unfractionated Heparin
St Elevation Myocardial Infarction patients undergoing primary percutaneous coronary intervention  Follow-up:

 

Venous thrombosis

These trials are included in meta-analysis concerning: LMWH in all type of patients, heparin (UFH or LMWH) in all type of patients, antithrombotics in all type of patients, antithrombotics in patients with cancer,

Enoxaparin vs acenocoumarol
Veiga ,2000 UFH, APTT 1.5–2.0d followed by Enoxaparin 4,000 IU qd
versus
UFH, APTT 1.5–2.0d followed by Acenocoumarol target INR 2-3
patients with objective diagnosis of DVT by Venography  Follow-up: 6-9 mo
open
 
Enoxaparin vs coumarin
González-Fajardo ,2008 long-term anticoagulant treatment with enoxaparin during at least 3 months
versus
long-term anticoagulant treatment with coumarin during at least 3 months
patients with symptomatic, unilateral, first-episode DVT  Follow-up: 1y, 5y
open, blind assessment
Spain 
extended enoxaparin vs standard treatment
Cesarone ,2003 Enoxaparin 100UL/Kg twice daily for 3 months
versus
coumadin (target INR 3) for 3 months.
patients with cancer with DVT  Follow-up: 3 months
NA
 
Deitcher ,2006 Enoxaparin 1mg/kg twice daily for 5 days followed by 1-1.5mg/kg daily for 175 days
versus
Enoxaparin 1mg/kg twice daily for 5 days followed by warfarin (target INR 2-3) for a total of 180 days
patients with cancer with DVT and/or PE  Follow-up: 12 months
none
 
Meyer ,2002 Enoxaparin 1.5 mg/kg daily for 3 monthsmag
versus
Enoxaparin 1.5 mg/kg daily for 4 days followed by warfarin (target INR 2-3) for 3 months
patients with cancer (solid or hematological; active or in remission but on treatment); with pulmonary embolism and/or DVT and a minimum life expectancy of 3 months  Follow-up: 3 months
outcome assessment blinded
 
Enoxaparin vs warfarin
Pini ,1994 UFH, APTT 1.3–1.9 followed by Enoxaparin 4,000 IU qd
versus
UFH, APTT 1.3–1.9 followed by Warfarin target INR 2-3.5
patients with objective diagnosis of DVT by Venography (diagnosed by strain-gauge plethysmography plus D-dimer latex assay and confirmed by venography)  Follow-up: 9 mo
open
 
Gonzalez-Fajardo ,1999 LMWH, 4,000 IU bid followed by Enoxaparin 4,000 IU qd
versus
UFH followed by Warfarin target INR 2-3
patients with objective diagnosis of DVT by Venography  Follow-up: 9 mo
open
 
Meyer ,2002 LMWH, 1.5 mg/kg qd followed by Enoxaparin 1.5 mg/Kg qd
versus
LMWH, 1.5 mg/kg qd followed by Warfarin target INR 2-3
patients with cancer and objective diagnosis of DVT by Venography/compression ultrasonography  Follow-up: 3 mo
open
 
Deitcher ,2003 LMWH: 1a, 1 mg/kg q12h; 1b, 1 mg/kg qd12h followed by Enoxaparin 1a: 1 mg/kg qd; 1b: 1.5 mg/kg qd
versus
LMWH, 1 mg/kg q12h followed by Warfarin target INR 2-3
patients with objective diagnosis of DVT  Follow-up: 6 mo
open
 
once daily enoxaparin vs twice daily enoxaparin
Merli ,2001 enoxaparin 1.5 mg/kg body weight once daily
versus
S.c. enoxaparin at fixed dosages of 1.0 mg/kg of body weight twice daily
patients with a symptomatic lower-extremity DVT confirmed by venography or ultrasonography (including patients with confirmed PE)  Follow-up:
double blind
Europe, United States of America and Australia, image/pj 
once daily enoxaparin vs UFH
Merli (once daily vs UFH) ,2001 Initial therapy with enoxaparin 1.5 mg/kg body weight once daily
versus
Initial therapy with dose-adjusted intravenous unfractionated heparin
patients with a symptomatic lower-extremity DVT confirmed by venography or ultrasonography (including patients with confirmed PE)   Follow-up: 3 months
partialy blinded
Europe, United States of America and Australia, image/pj 
Enoxaparin vs unfractionated heparin
Simonneau et al ,1993 Enoxaparin Subcutaneous twice daily for 0 Days, 100 U/kg BID
versus
unfractionated heparin intravenous APPTx1.5-2.5
  Follow-up: 3 Months

 

Acute coronary syndrome

These trials are included in meta-analysis concerning: heparin (UFH or LMWH) in all type of patients, antithrombotics in all type of patient, antithrombotics in unstable angina,

enoxaparin vs unfractionated heparin
RESCUE
NCT00077818
Enoxaparin
versus
unfractionated heparin
patients diagnosed with acute coronary syndrome in the emergency department   Follow-up: 30 days
open
 
enoxaparin vs tinzaparin
EVET ,2005 enoxaparin, 100 IU/kg subcutaneously twice daily +aspirin for 7 days
versus
tinzaparin, 175 IU/kg subcutaneously once daily +aspirin for 7 days
patients with non-ST-segment elevation acute coronary syndromes   Follow-up: 30 days
open
 
enoxaparin vs UFH (on top of aspirin)
ESSENCE ,1997 enoxaparin 1mg/kg, twice daily during 48h-8days
versus
continuous intravenous unfractionated heparin
patients with angina at rest or non–Q-wave myocardial infarction  Follow-up: 14 days (30 days)
Double blind
United states, Canada, South America, Europe 
TIMI 11 B (short term) ,1998 enoxaprin during both the acute phase and outpatient phase
versus
intravenous UFH for >=3 days (followed by subcutaneous placebo injections)
unstable angina/non–Q-wave myocardial infarction  Follow-up: 8 days (43 days)
double blind
North America, South America, 
SYNERGY ,2005
NCT00043784
Enoxaparin 1 mg/kg twice daily
versus
unfractionated heparin
high-risk patients with acute coronary syndromes   Follow-up: 30 days
open
12 countries 
INTERACT ,2006 enoxaparin (1 mg/kg subcutaneously twice daily) for 48 hours (+eptifibatide and aspirin)
versus
intravenous UFH (70 U/kg bolus followed by 15 U/kg per hour adjusted to an activated partial thromboplastin time of 1.5-2 times control) for 48 hours (+eptifibatide and aspirin)
high-risk patients with ACS receiving aspirin and eptifibatide  Follow-up: 30 days (2.5y)
open
Canada 
TIMI 11 B (long term) ,1998 enoxaprin during both the acute phase (IV) and outpatient phase (SC)
versus
intravenous UFH for >=3 days (followed by subcutaneous placebo injections)
unstable angina/non–Q-wave myocardial infarction   Follow-up: 43 days
double blind
North America, South America, 

Acute myocardial infarction

These trials are included in meta-analysis concerning: antithrombotics in all type of patients, heparin (UFH or LMWH) in patients eligible to receive fibrinolytic therapy,

Enoxaparin vs placebo
AMI-SK ,2002 Enoxaparin 30 mg IV bolus, 1 mg/kg for 3–8 d
versus
placebo
patients with evolving myocardial infarction, Age >=18 y, STEMI  Follow-up: 30 d
Double-blind
 
Enoxaparin vs UFH
ASSENT 3 ,2001 Enoxaparin 1 mg/kg BID, <=7d
versus
UFH 60 U/kg bolus, then 12 IU/kg per h for 48 h
patients with acute myocardial infarction  Follow-up: 30 d
open
 
HART II ,2001 Enoxaparin 1 mg/kg BID, <=3d
versus
UFH 4000–5000 IU bolus, then 15 IU/kg per hour for >=3d
patients undergoing reperfusion therapy with an accelerated recombinant tissue plasminogen activator regimen and aspirin for AMI  Follow-up: 5–7 d
open
 
Baird ,2002 Enoxaparin 40 mg TID, 4 d
versus
UFH 5000 IU bolus, then 30 000 IU over 24 h for 4d
patients receiving fibrinolytic therapy following acute myocardial infarction   Follow-up: 90 d
90-min TIMI flow
 
ENTIRE-TIMI 2 ,2002 Enoxaparin 1 mg/kg BID, <=8d
versus
UFH 60 IU/kg, then 12 IU/kg per h for >=3d
Patients with ST-elevation MI presenting <6 hours from symptom onset were   Follow-up: 30 d
open
 
ASSENT 3 Plus ,2003 Enoxaparin 1 mg/kg BID, <=7d
versus
UFH 60 IU/kg, then 12 IU/kg per h for >=3d
patients with ST-elevation myocardial infarction  Follow-up: 30 d
open
 

Superficial thrombophlebitis

These trials are included in meta-analysis concerning: antithrombotics in superficial thrombophlebitis of the leg,

enoxaparin vs placebo
Stenox (enoxaparin 40mg) ,2003 LMWH (enoxaparin) (s.c. 40 mg) for 8-12 days
versus
placebo.
patients with ST of at least 5 cm on ultrasonography examination  Follow-up:

 
STENOX (enoxaparin 1.5mg/hg) ,2003 enoxaparin (s.c. 1.5 mg/kg)for 8-12 days
versus
placebo
patients with St of at least 5 cm on ultrasonography examination  Follow-up:

 

Pulmonary embolism

These trials are included in meta-analysis concerning: antithrombotics in all type of patients,

Enoxaparin vs unfractionated heparin
PREPIC ,1998 Enoxaparin, 1 mg/kg twice daily, 8-12 days
versus
Unfractioned heparin: bolus 5000 IU, infusion 500 IU/kg per day
patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism   Follow-up: 2 y
open
 
Merli sub group ,2001 Enoxaparin, 1mg/kg twice daily or 1.5 mg/kg once daily, 5 days
versus
Unfractioned heparin: according nomogram at local institution
patients with confirmed pulmonary embolism  Follow-up: 3 mo
open
16 countries 

Heart failure

These trials are included in meta-analysis concerning: antithrombotics in patients hospitalized for heart failure,

enoxaparin vs UFH
THE-PRINCE (Kleber) ,2003 enoxaparin 40mg once daily for 10+/-2 days
versus
UFH 5000 IU 3 times daily for 10+/-2 days
patients hospitalized for severe respiratory disease or heart failure (NYHA III, IV)  Follow-up:
open
germany 



Entry terms: Enoxaparine, Enoxaparin, Enoxaparine, PK-10,169, PK 10,169, PK10,169, PK-10169, PK 10169, PK10169, EMT-967, EMT 967, EMT967, Lovenox, Clexane, EMT-966, EMT 966, EMT966




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