A Multicenter, Two-Period, Observational Cohort Study to evaluate Patient Stabilization and Cardiovascular Resource Utilization Prior to, and After, the Addition of Tirofíban to Standard Therapy for Acute Coronary Ischemic Syndromes (Unstable Angina/Non- Q-Wave Myocardial Infarction).

Not Applicable

• Conditions: -I52; I52

• Registration Number: PER-041-99
• Lead Sponsor: MERCK & CO.INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-01-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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 < 12 hours after discontinuation of study medication.
8. Allergy or intolerance to aspirin or heparin (including heparin-induced thrombocitopenia).
9. Patients with severe cardiovascular disease requiring urgent therapy:
•History or symptoms (e.g., pain radiating to the back) or findings suggestive of aortic dissection.
•Acute pulmonary edema or severe congestive heart failure (New York Heart Association Functional Class III or IV).
•Angina precipitated by obvious provoking factors (e.g., arriiythmia, severe anemia, hypotension, or hyperthyroidism).
•Uncontrolled, severe cardiac arrhythmia (resulting in hemodynamic instability).
•Sustained systolic blood pressure < 95 mmHg or evidence of cardiogenic shock at enrollment.
•Presence of a > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified