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Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention (STATUS PCI)

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ClinicalTrials.gov Identifier: NCT01464671
Recruitment Status : Terminated (DSMB halted the study early due to futility. There were no safety concerns.)
First Posted : November 3, 2011
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Allen Jeremias, Stony Brook University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 stress test without chest pain) that undergo percutaneous coronary intervention (PCI).

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Bivalirudin Drug: Heparin Phase 4

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.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention
Study Start Date : July 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Bivalirudin
Anticoagulation during percutaneous coronary intervention
 Drug: Bivalirudin
Anticoagulation during percutaneous coronary intervention
Other Name: Angiomax
Drug: Heparin
Anticoagulation during percutaneous coronary intervention
Active Comparator: Unfractionated Heparin
Anticoagulation during percutaneous coronary intervention
 Drug: Heparin
Anticoagulation during percutaneous coronary intervention


Outcome Measures
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Primary Outcome Measures :
  1. Bleeding events [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. MACE [ Time Frame: 1 year ]
    Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is male or female ≥ 18 years of age.
  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:

  1. Patients in cardiogenic shock.
  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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464671


Locations
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Allen Jeremias, MD Stony Brook University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Allen Jeremias, Associate Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT01464671     History of Changes
Other Study ID Numbers: 119778 (IRB ID)
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Allen Jeremias, Stony Brook University:
Coronary Artery Disease
Stable Angina
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Bivalirudin
 Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors