None listed
Conditions
Interventions
Group A Type of group
The standard therapy that each patient is receiving in their health center will be monitored without adding any medication.
Group name:Group B Type of group
Tirofiban will be added to the standard therapy that each patient is receiving.
Tirofiban I.V. loading infiision of 0.40 pg/kg/min over 30 minutes followed by tirofiban I.V. maintenance infusión of 0.10 pg/kg/min for 47.5 to 107.5 hours (48-108 hours total).
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The study population will consist of patients of either gender who present to the hospital with anginal symptoms suggestive of cardiac ischemia with their most recent episode of anginal pain within 24 hours preceding study enrollment. 2. The symptoms of angina might be associated with at least one of the following: a. ECG evidence of myocardial ischemia b. abnormal cardiac enzymes c. abnormal troponins d. a history of coronary artery disease 3. The study population will be >18 years of age and above the age of consent and <85 years of age.
Exclusion criteria
Exclusion criteria: Patients who fulfill the above inclusion criteria but who manifest any of the following exclusion criteria at baseline will not be eligible for the study: 1. Known or suspected pregnancy. (Women of childbearing potential must have a serum [or urine] b-hCG pregnancy test obtained at baseline 2. Presence of new pathologic Q-waves (>0.03 sec in duration) or ST-segment elevation over 0.1 mV in two contiguous leads persisting for over 0 minutes, suggestive of evolving acute Q-wave myocardial infarction. 3. Patient with a contraindication to anticoagulation/increased bleeding risk: • Past or present bleeding disorder including a history of the following within 3 months prior to enrollment: gastrointestinal bleeding, gross (visible) hematuria. Any patient with a known coagulopathy, platelet disorder, or history of thrombocytopenia is excluded. • Any persistent recording of systolic blood pressure exceeding ISOmmHg and/or diastolic blood pressure exceeding 110 mm Hg at time of enrollment. • Any history of stroke or other intracranial pathology at any time, or transient ischemic attack within 1 year. • Major surgery including CABG, any ophthalmologic surgery or biopsy (noncutaneous) within 1 month prior to enrollment. Severe physical trauma within 1 month prior to enrollment. Prolonged cardiopulmonary resuscitation within the 2 weeks prior to enrollment. • Acute pericarditis. • Presence of known significant retinopathy (i.e., hemorrhages or exudates). 4. Thrombolytic therapy within 48 hours prior to enrollment. 5. Treatment with abciximab within the past 14 days. (Patients who have previously received an intravenous GP Ilb/IIIa receptor antagonist can be included provided they have not received treatment within the past 14 days.) 6. Patients who have received > 500 mg of ticlopidine or > 75 mg clopidogrel over the past 24 hours, or who have received low molecular weight heparin within 12 hours. 7. Patients requiring warfarin therapy for any medical indication prior to enrollment or 50% left main lesion unprotected by bypass grafts. • Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease. 10. Patients with any other medical condition which, in the investigators opinion, makes survival for the duration of the study unlikely, or would othenvise interfere with optimal participation in the study or produce a significant risk to the patient. • History of recent or ongoing alcohol abuse or other drug abuse. • Patients with a history of cancer must be considered disease free, with the exception of ba
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Patient stabilization as defined by the absence of any of the following: •refractory/recurrent ischemia or new MI, •prompting urgent/emergency intervention/revascularization (within 24 hours), or prompting transfer to a tertiary care facility (within 24 hours). •Death and (new) myocardial infarction, •hospital readmissions for acute coronary ischemic syndromes (UA/NQWMI, acute myocardial infarction and other •CHD related conditions and revascularization procedures (CABG, PTCA) will also be collected. Measure:Efficacy Timepoints:During the duration of the study and follow up ; Outcome name:Resource utilization measurements will encompass five general categories: time in the hospital, selected diagnostic procedures, major therapeutic procedures, specific cardiac medications and transfusions. Measure:Resource Utilization Timepoints:Duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Safety will be assessed by • Major and minor bleeding (TIMI criteria), • Need for PRBC or platelet transfusions, • Rates of spontaneously reported clinical adverse experiences, • Spontaneously reported changes in clinical laboratory values including CBC. Measure:Safety Timepoints:Duration of the study | — |
Outcome results
None listed