None listed
Conditions
Interventions
Tirofiban + Enoxaparin Type of group
Patients randomized to tirofiban and enoxaparin will receive a loading dose of tirofiban of 0.4 ug/kg/min over 30 minutes followed by a maintenance infusion at 0.1 ug/kg/min for a total infusion period of at least 48 hours and maximum duration of 96 hours. For patients undergoing PTCA between Hours 84 to 96, tirofiban infusion may be continued for up to 108 hours. enoxaparin will be administered concurrently with tirofiban except after PTCA which can occur after a minimum of 24 to 48 hours of ti
Patients randomized to tirofiban and UH will receive a loading dose of tirofiban of 0.4 [ig/kg/min over 30 minutes followed by a maintenance infusión at 0.1 [ug/kg/min for a total infusion period of at least 48 hours and a maximum duration of 96 hours. For those patients undergoing PTCA between Hours 84 to 96, tirofiban infusion may be continued for up to 108 hours. Unfractionated heparin will be administered concurrently with tirofiban except after PTCA which can occur after a minimum of 24 to
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: •Patients must meet ALL, of the following: •Patients must be men or women with their most recent episode of anginal pain occurring within the 24 hours preceding randomization, and be >18 years of age •Patients must present to the hospital with prolonged or repetitive chest pain indicating either unstable angina or non-Q-wave myocardial infarction. All patients will be required to have anginal symptoms suggestive of cardiac ischemia with one of the following clinical presentations: 1) Accelerating pattern of anginal pain (episodes of angina that are more frequent, severe, longer in duration and/or precipitated by less exertion), 2) Prolonged ^20 minutes) or recurrent anginal pain occurring at rest or with minimal effort 3) Anginal pain at rest or with minimal exertion occurring >48 hours but within 14 days after an acute Q-wave myocardial infarction. •The symptoms of angina MUST also be associated with at least ONE of the conditions below (1 or 2). 1) Electrocardiographic evidence of myocardial ischemia manifested by: a) New persistent or transient ST-segment depression >0.1 mV (0.08 seconds after the J-point) in two contiguous leads, or b) Transient or reversible (0.1 mV (0.08 seconds after the J-point) in two contiguous leads, or c) New persistent or transient T-wave inversion >0.3 mV (or pseudonormalization >0.1 mV above the isoelectric line) in at least three leads (any combination of three anatomically consistent extremity and precordial leads (excluding VI)). OR 2) Abnormal cardiac enzymes defined as: a) CK-MB, within the preceding 24 hours greater than the upper limit of normal, b) total CK >2 times the upper limit of normal (if CK-MB not available), c) troponin level greater than the upper limit of normal. d. Women of childbearing potential must have a serum P-HCG pregnancy test obtained at the time of randomization
Exclusion criteria
Exclusion criteria: Patients who fulfill the inclusion criteria but who manifest any of the following exclusion criteria at the time of randomization will not be eligible for the study: • Known or suspected pregnancy. • Patients with a contraindication to anticoagulation or at increased bleeding risk: 1) Recent (500 mg of ticlopidine or >75 mg of clopidogrel over the past 24 hours. 13) Patients requiring warfarin therapy for any medical indication. 14) Patients scheduled to undergo spinal/epidural anesthesia or spinal puncture (because of the risk of epidural or spinal hematomas that have caused neurologic injury, including long-term or permanent paralysis, in patients who received low molecular weight heparins). • c. Allergy or hypersensitivity to tirofiban, aspirin, heparin (including low molecular weight heparin), or any components of these products (e.g., hypersensitivity to pork products as enoxaparin is derived from porcine intestinal mucosa). • d. Patients with severe cardiovascular disease requiring urgent therapy. 1) History or symptoms (e.g., pain radiating to the back) suggestive of aortic dissection. 2) Patients with acute pulmonary edema (rales present over more than 50% of the lung fields) or patients with severe congestive heart failure (New York Heart Association Functional Class III or IV). 3) Angina precipitated by obvious provoking factors (e.g., arrhythmia, infection, severe anemia, or hyperthyroidism). 4) Patients with uncontrolled severe (resulting in hemodynamic instability) cardiac arrhythmias. 5) Sustained supine, sitting or standing systolic blood pressure 50% left main lesion unprotected by bypass grafts. 7) Patients with significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease. • e. Patients with any medical condition, which, in the investigator´s opinion, makes survival for the durat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Bleeding • hemoglobin and hematocrit • TIMI criteria Thrombocytopenia • Platelets less than 90000 / mm3 Presence of adverse effects Measure:Safety measurement Timepoints:Bleeding will be measured during the duration of the study Platelets will be measured after 7 days after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Progression to cardiovascular endpoints (a prespecified composite of any of the following clinical events: death from any cause, new myocardial infarction [periprocedural and nonperiprocedural], refractory ischemia prompting intervention within 24 hours, and rehospitalization for unstable angina) will be assessed. Measure:Clinical Outcome Timepoints:During hospitalization and up to Day 30. | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed