The TETAMI trial: the safety and efficacy of subcutaneous enoxaparin versus intravenous unfractionated heparin and of tirofiban versus placebo in the treatment of acute myocardial infarction for patients not thrombolyzed: methods and design.
Patients with acute myocardial infarction (AMI) who do not receive early reperfusion therapy are at high risk of reinfarction or death, and the efficacy and safety of antithrombotic therapy in this group of patients has not been evaluated. Enoxaparin is a low-molecular-weight heparin (LMWH) that has previously been shown to reduce the incidence of ischemic events in patients with unstable angina or non-Q-wave MI. The principal aims of the TETAMI study are to investigate the efficacy and safety of treatment with enoxaparin or tirofiban (a glycoprotein IIb/IIIa receptor antagonist) alone or in combination for 2 to 8 days in patients with AMI who are not eligible for early reperfusion therapy. In this 2 by 2 factorial design study approximately 900 patients will be randomly assigned, in a blinded manner, to one of four treatments: enoxaparin alone, enoxaparin plus tirofiban, unfractionated heparin (UFH), or UFH plus tirofiban, with appropriate matched placebos. The primary end point is the composite of death, recurrent AMI, and recurrent angina, analyzed at 30 days after AMI. The design and methods of the TETAMI study are described in this article.
Cohen
M
M
Hahnemann University Hospital, Philadelphia, Pennsylvania 19102-1192, USA. marc.cohen@tenethealth.com
Maritz
F
F
Gensini
G F
GF
Danchin
N
N
Timerman
A
A
Huber
K
K
Gurfinkel
E P
EP
White
H
H
Fox
K A
KA
Vittori
L
L
Le-Louer
V
V
Bigonzi
F
F
D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D004359:Drug Therapy, Combination; D017984:Enoxaparin / Q000008:administration & dosage* / Q000592:standards / Q000633:toxicity; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000592:standards / Q000633:toxicity; D006493:Heparin / Q000008:administration & dosage* / Q000592:standards / Q000633:toxicity; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D010919:Placebos; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D012008:Recurrence; D015996:Survival Rate; D000077466:Tirofiban; D014443:Tyrosine / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000592:standards / Q000633:toxicity
D017984:Enoxaparin; D005343:Fibrinolytic Agents; D010919:Placebos; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D014443:Tyrosine; D006493:Heparin; D000077466:Tirofiban