A Randomized, Parallel, Double-Blind, Safety Study of Enoxaparin Versus Unfractionated Heparin in Tirofiban and Aspirin-Treated Patients With Unstable Angina/Non-Q-Wave Myocardial Infarctio
- Conditions
- I219-I200 Unstable angina-I219 Acute myocardial infarction, unspecifiedUnstable anginaAcute myocardial infarction, unspecifiedI200
- Registration Number
- PER-046-99
- Lead Sponsor
- MERCK SHARP & DOHME PERÚ S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
•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 (<20 minutes) ST-segment elevation >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
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 (<1 year) or active bleeding disorder including gastrointestinal bleeding, gross hematuria, or known presence of occult blood in the stool.
Any patient with a known coagulopathy, platelet disorder, or history of thrombocytopenia.
2) Any persistent recording of systolic blood pressure exceeding 180 mm Hg and/or diastolic blood pressure exceeding 110 mm Hg at time of enrollment.
3) Any history of hemorrhagic cerebrovascular disease or active intracranial pathologic process (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm). Any history of cerebrovascular disease (e.g., stroke or transient ischemic attack) within 1 year.
4) Traumatic or prolonged cardiopulmonary resuscitation within the 2 weeks prior to study enrollment.
5) Severe physical trauma within 1 month prior to study enrollment.
6) Major surgery including CABG, any ophthalmologic surgery or biopsy (noncutaneous) within 1 month prior to study enrollment.
7) Active peptic ulcer disease within the 3 months prior to study enrollment.
8) Acute pericarditis.
9) Presence of known significant retinopathy (i.e., hemorrhages or neovascularization).
10) Thrombolytic therapy within the 48 hours prior to enrollment.
11) Treatment with abciximab within the past 14 days or treatment with eptifibatide within the past 12 hours.
12) Patients who are on chronic ticlopidine or clopidogrel or who have received >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 <95 mm Hg or evidence of cardiogenic shock at randomization.
6) Presence of a >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Bleeding<br>• hemoglobin and hematocrit<br>• TIMI criteria<br>Thrombocytopenia<br>• Platelets less than 90000 / mm3<br>Presence of adverse effects<br>Measure:Safety measurement<br>Timepoints:Bleeding will be measured during the duration of the study<br>Platelets will be measured after 7 days after the end of treatment.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Progression to cardiovascular endpoints (a prespecified composite of any of the following clinical events: death from any cause, new<br>myocardial infarction [periprocedural and nonperiprocedural], refractory ischemia prompting intervention within 24 hours, and rehospitalization for unstable angina) will be assessed.<br>Measure:Clinical Outcome<br>Timepoints:During hospitalization and up to Day 30.<br>