Status:
TERMINATED
Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention
Lead Sponsor:
Stony Brook University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive st...
Detailed Description
The purpose of this study is to compare in a randomized, controlled, single-blinded, 1:1 fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia undergoing PCI. Seco...
Eligibility Criteria
Inclusion
- The patient is male or female ≥ 18 years of age.
- The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain).
- The patient is scheduled for coronary angiography, with possible angioplasty.
- 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).
- The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
- 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.
- Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
Exclusion
- Patients in cardiogenic shock.
- Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI.
- Known history of heparin-induced thrombocytopenia.
- Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent.
- Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study.
- Pregnant women or nursing mothers.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01464671
Start Date
July 1 2009
End Date
September 1 2014
Last Update
November 20 2014
Active Locations (1)
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1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794