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fibrinolysis in acute myocardial infarction for all type of patients, clinical trials results

accelerated t-PA versus APSAC
TAPS, 1992
front-loaded administration of rt-PA
versus
APSAC
patients with acute myocardial infarction.open
TIMI 4, 1994
front-loaded rt-PA
versus
APSAC
patients with acute myocardial infarction double blind
Follow-up duration: hospital stay
accelerated t-PA versus streptokinase
GUSTO tPA Hiv, 1993
tPA accéléré (15 mg en bolus, puis 0.75 mg/kg en 30 min sans dépasser 50 mg puis 0.5 mg/kg en 60 min sans dépasser 35 mg) + héparine en IV (5000 U en bolus, 1000 U/h (de préférence 1200 U/h si > 80 kg), poursuivi au moins 48 h)
versus
Streptokinase 1.5 MU en 60 min + héparine SC (12500 U 2 fois/j commencée 4h après thrombolytique) combiné à streptokinase (1.5 MU en 60 min) + héparine en IV (5000 U en bolus, puis 1000 U/h (1200 U/h si > 80 kg) poursuivi au moins 48 h)
Hommes et femmes
Follow-up duration: 30 d
International 15 countries
accelerated t-PA versus t-PA
RAAMI, 1992
100 mg of rt-PA accelerated 90-min regimen (15-mg bolus followed by 50 mg over 30 min, then 35 mg over 60 min)
versus
100 mg of rt-PA standard 3-h infusion regimen (an initial 10-mg bolus followed by 50 mg for the 1st h, then 20 mg/h for 2 h
patients with acute myocardial infarction within 6h from onset of chest painopen
Follow-up duration: hospital stay
US
anistreplase versus streptokinase
TEAM 2, 1991
anistreplase (30 units/2-5 min)
versus
streptokinase (1.5 million units/60 min
less than 76 years of age with electrocardiographic ST segment elevation who could be treated within 4 hours of symptom onsetdouble blind
APSAC versus control
APSIM, 1989
APSAC 30 U over 5 min
versus
control (conventional heparin therapy, 5,000 IU in a bolus injection)
patients with a first acute myocardial infarction within 5 h after the onset of symptomsopen
Follow-up duration: 3 weeks
France
APSAC versus placebo
AIMS, 1988
APSAC 30U IV in 5 min
versus
Placebo
Hommes et femmes, < 70 ansdouble blind
Follow-up duration: 1 y
German Multicenter Trial, 1988
APSAC 30 unités en IV en 5 min, puis héparine en IV (17 U/kg/h) 4 h après l'injection d'APSAC
versus
Héparine 5000 U en bolus en IV, puis 17 U/kg/h
Hommes et femmes, < 70 ans
Follow-up duration: 28 jours
APSAC versus streptokinase
ISIS III (SK/APSAC), 1992
Streptokinase 1.5 MU infused over about 1 h
versus
anisoylated plasminogen-streptokinase activator complex (APSAC), anistreplase: 30 U over about 3 min
patients within 24 h of the onset of suspected acute myocardial infarction double blind
Follow-up duration: 6 mo
International 17 countries
APSAC versus t-PA
TEAM 3, 1992
APSAC, 30 U/2 to 5 min
versus
rt-PA, 100 mg/3 h,
patient with ST elevalation within 4h of the onset of symptomsdouble blind
Follow-up duration: 1 months
bolus t-PA versus accelerated t-PA
COBALT, 1997
of 50 mg of alteplase over a period of 1 to 3 minutes followed 30 minutes later by a second bolus of 50 mg (or 40 mg for patients who weighed less than 60 kg).
versus
weight-adjusted, accelerated infusion of 100 mg of alteplase
patients with acute myocardial infarctiondouble blind
Follow-up duration: 30 days
lanoteplase versus accelerated t-PA
InTIME-II, 2000
lanoteplase 120 KU. kg(-1) as a single intravenous bolus
versus
up to 100 mg accelerated alteplase given over 90 min
patients presenting within 6 h of onset of ST elevation acute myocardial infarctiondouble blind
Follow-up duration: 30 days
worldwide
recombinant staphylokinase versus t-PA
STAR, 1995
recombinant staphylokinase (10 or 20 mg given intravenously over 30 minutes)
versus
weight-adjusted rt-PA over 90 minutes
patients with evolving myocardial infarction of < 6 hours' duration and with ST-segment elevation open
Follow-up duration: 90 min
Belgium
reteplase versus accelerated t-PA
GUSTO III, 1997
reteplase, in two bolus doses or 10 MU each given 30 minutes apart
versus
alteplase, up to 100 mg infused over a period of 90 minutes
patients within 6 hours after the onset of symptoms with ST-segment elevation or bundle-branch block open
Follow-up duration: 30 days
20 countries
RAPID-2, 1996
10 plus 10 megaunits double bolus of reteplase
versus
front-loaded alteplase
patients with acute myocardial infarction within 12h from onset of ischemic chest painopen
Follow-up duration: 35 days
USA, Germany
reteplase versus streptokinase
INJECT, 1995
Reteplase 2 bolus de 10 MU à 30 min d'intervalle
versus
Streptokinase 1.5 MU en IV en 60 min
patients with symptoms and electrocardiographic criteria consistent with acute myocardial infarction within 12 h from onset of symptoms double blind
Follow-up duration: 6 mo
Europe
saruplase versus streptokinase
COMPASS, 1998
saruplase 20-mg bolus and 60-mg infusion over 60 min
versus
streptokinase 1.5-MU infusion over 60 min
patients with symptoms compatible with those of acute myocardial infarction for < 6 hdouble blind
Follow-up duration: 1 y
PRIMI (vs SK), 1989
sarupalse 20 mg bolus followed by 60 mg infusion for 60 min
versus
1.5 million IU streptokinase infused over 60 min
patients with acute myocardial infarction were within 4 h of onset of symptoms double blind
Follow-up duration: ND
saruplase versus t-PA
SESAM, 1997
saruplase 80 mg/hour
versus
alteplase 100 mg every 3 hours
patients with acute myocardial infarction open
Follow-up duration: hospital stay
Europe
saruplase versus urokinase
PRIMI (vs UK), 1989
20 mg bolus followed by 60 mg infusion for 60 min
versus
80 mg recombinant pro-urokinase
with a first acute myocardial infarction within 4 h of onset of symptoms double blind
streptokinase versus placebo
EMERAS (7-12h), 1993
intravenous streptokinase 1.5 MU
versus
placebo
patients presenting 7-12 h from symptom onsetdouble blind
EMERAS (all delay), 1993
streptokinase 1.5 MU
versus
placebo
patients entering hospital up to 24 h after the onset of suspected acute myocardial infarctiondouble blind
south america
GISSI I, 1986
Streptokinase 1.5 MU en perfusion IV en 1 heure
versus
usual care
patients within 12 h after the onset of symptoms and with no contraindications to SK open
Follow-up duration: 1 y
ISAM, 1986
1.5 million IU of streptokinase over 1h
versus
Placebo
patients within six hours after the onset of symptoms of myocardial infarctiondouble blind
Follow-up duration: 21 days
ISIS 2 pilot, 1987
streptokinase 1.5 MU
versus
placebo
patients with suspected acute myocardial infarction double blind
ISIS-2 (SK), 1988
1-hour intravenous infusion of 1.5 MU of streptokinase
versus
Placebo
patients within 24h of the onset of suspected acute myocardial infarction double blind
Follow-up duration: 15 mo
Western Washington Intravenous Trial, 1988
NCT00000507
Streptokinase en IV, 1.5 M UI en 60 min après injection de benadryl 50 mg en IV et hydrocortisone 100 mg en IV; héparine en IV 1000 UI/h 2h après la streptokinase puis warfarine pendant au moins 3 mois
versus
Traitement standard, avec ou sans anticoagulant (décidé par le médecin)
Hommes et femmes, < ou = 75 ans
Follow-up duration: 1.4 y
t-PA versus placebo
ASSET, 1988
rt-PA 100 mg
versus
Placebo
patient with suspected acute myocardial infarction double blind
Follow-up duration: 6 months
LATE, 1993
intravenous alteplase (100 mg over 3 h)
versus
placebo
patients with symptoms and electrocardiographic criteria consistent with AMI between 6 and 24 h from symptom onsetdouble blind
Follow-up duration: 6 mo
TAMI 6, 1992
tissue-type plasminogen activator 100 mg over 2 hours
versus
placebo
patients with 6 to 24 hours of symptoms and ECG ST elevation double blind
Follow-up duration: 6 months
USA
t-PA versus streptokinase
International Study Group, 1990
tPA 100 mg en IV en 3 h (10 mg en bolus, puis 50 mg en 1 h, puis 20 mg/h pendant 2 h)
versus
Streptokinase 1.5 MU en IV de 30 à 60 min
patients with suspected acute myocardial infarction of less than 6 h duration double blind
Follow-up duration: 6 mo
Centre Illinois, 1993
t-PA 10 mg bolus, followed by 50 mg in the first hour, and 20 mg/hour for the next 2 hours
versus
SK 375 000 IU bolus, followed by 1 125 000 IU/1 hage/pj
patients with AMI within 3h from onset of chest painsingle blind
USA
Cherng, 1992
100 mg of rTPA over 3 hours (with early heparinization)
versus
1,500,000 units of streptokinase over 1 hour
patients with acute myocardial infarction open
Follow-up duration: hospital stay
Taiwan
ECSG, 1985
0.75 mg rt-PA/kg over 90 min
versus
1 500 000 IU streptokinase over 60 min
patients with acute myocardial infarction of less than 6 h durationsingle-blind
Europe
GISSI II, 1990
alteplase 100 mg infused intravenously over 3 h
versus
streptokinase 1.5 MU infused intravenously over 30-60 min
patients with acute myocardial infarction within 6 h from onset of symptomsopen
Follow-up duration: 6 mo
International 14 countries
ISIS III (SK/tPA), 1992
Streptokinase 1.5 MU en IV d'une heure
versus
tPA 0.04 MU/kg en IV en bolus d'1 min, puis 0.36 MU/kg en 1 h, puis 0.067 MU/kg/h pendant 3 h
Hommes et femmesdouble blind
Follow-up duration: 6 mo
International 17 countries
PAIMS, 1989
intravenous cumulative dose of 100 mg rt-PA
versus
.5 million units streptokinase
patients with acute myocardial infarction less than 3 h oldopen
Italy
TIMI-1, 1987
NCT00000505
rt-PA, 40, 20, and 20 mg in successive hours
versus
SK 1.5 million units over 1 hr
patients with evolving acute myocardial infarction within 7 hr of the onset of symptoms double blind
USA
White, 1989
rt-PA 100 mg over three hours
versus
streptokinase 1.5 million units over 30 minutes
patients with AMIdouble blind
New Zealand
t-PA versus urokinase
TAMI 5 (t-PA vs uroK), 1991
accelerated t-PA 100mg over 3h
versus
urokinase IV bolus 1.5 MU followed by 1.5 MU over 90min
patient with acute myocardial infarctionopen
t-PA + streptokinase versus streptokinase
GUSTO tPA-SK Hiv, 1993
tPA en IV 1 mg/kg, sans dépasser 90 mg, dont 10 % en bolus + streptokinase 1 MU en 60 min + héparine en IV (5000 U en bolus, 1000 U/h (de préférence 1200 U/h si > 80 kg), poursuivi au moins 48 h)
versus
Streptokinase 1.5 MU en 60 min + héparine SC (12500 U 2 fois/j commencée 4h après thrombolytique) combiné à streptokinase (1.5 MU en 60 min) + héparine en IV (5000 U en bolus, puis 1000 U/h (1200 U/h si > 80 kg) poursuivi au moins 48 h)
Hommes et femmes
Follow-up duration: 30 d
International 15 countries
t-PA + urokinase versus t-PA
TAMI 5 (t-PA+uroK vs tPA), 1991
t-PA + urokinase
versus
t-PA
patient with acute myocardial infarction open
t-PA half dose versus t-PA
KAMIT, 1991
half-dose (50 mg) t-PA with streptokinase (1.5 MU) during 1 hour
versus
t-PA (100 mg) during 3 hours
patients within 6 hours of myocardial infarction open
Follow-up duration: hospital stay
USA
tenecteplase versus accelerated t-PA
ASSENT-2, 1999
Tenecteplase en IV bolus (dose en fonction du poids: 30 mg si < 60 kg; 35 mg si poids entre 60 et 69.9 kg; 40 mg pour les 80-89.9 kg; 50 mg si > ou = 90 kg
versus
Alteplase en IV, bolus de 15 mg, puis 0.75 mg/kg (sans dépasser 50 mg) en 30 min puis 0.50 mg/kg (sans dépasser 35 mg) en 60 min
patients with acute myocardial infarction of less than 6 h duration double blind
Follow-up duration: 30d
29 countries
urokinase versus control
USIM, 1991
urokinase bolus dose of 1 million U repeated after 60 minutes plus heparin
versus
control (heparin alone)
patients with acute myocardial infarction within 4 hours of the onset of pain open
Follow-up duration: in hospital
Italy

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