Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention
NCT ID: NCT01464671
Last Updated: 2014-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
260 participants
INTERVENTIONAL
2009-07-31
2014-09-30
Brief Summary
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The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.
Detailed Description
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Secondary study endpoints will include:
* Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
* Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as defined by the REPLCE-2 criteria.
* Cardiac death in-hospital and up to 30 days post discharge.
* MI in-hospital and up to 30 days post discharge.
* CVA in-hospital and up to 30 days post discharge.
* Incidence of all-cause mortality at 6 months and 1 year.
* MACE at 6 months and 1 year.
* Incidence of acute (0-24 hours post procedure) stent thrombosis rates.
* Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates.
* Length of hospital stay (LOS)
* Economic analysis (total cost during hospitalization) and up to 30 days post discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bivalirudin
Anticoagulation during percutaneous coronary intervention
Bivalirudin
Anticoagulation during percutaneous coronary intervention
Heparin
Anticoagulation during percutaneous coronary intervention
Unfractionated Heparin
Anticoagulation during percutaneous coronary intervention
Heparin
Anticoagulation during percutaneous coronary intervention
Interventions
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Bivalirudin
Anticoagulation during percutaneous coronary intervention
Heparin
Anticoagulation during percutaneous coronary intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain).
3. The patient is scheduled for coronary angiography, with possible angioplasty.
4. The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI).
5. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
6. The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study.
7. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
Exclusion Criteria
2. Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI.
3. Known history of heparin-induced thrombocytopenia.
4. Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent.
5. Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study.
6. Pregnant women or nursing mothers.
18 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Allen Jeremias
Associate Professor
Principal Investigators
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Allen Jeremias, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Locations
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Stony Brook University Medical Center
Stony Brook, New York, United States
Countries
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Other Identifiers
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119778 (IRB ID)
Identifier Type: -
Identifier Source: org_study_id