Back to resultsAngiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention (STATUS PCI)
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bivalirudin
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Stable Angina, Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Stony Brook University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bivalirudin
Unfractionated Heparin
Arm Description
Anticoagulation during percutaneous coronary intervention
Anticoagulation during percutaneous coronary intervention
Outcomes
Primary Outcome Measures
Bleeding events
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
MACE
Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
Full Information
NCT ID
NCT01464671
First Posted
October 31, 2011
Last Updated
November 19, 2014
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT01464671
Brief Title
Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention
Acronym
STATUS PCI
Official Title
STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
DSMB halted the study early due to futility. There were no safety concerns.
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Stable Angina, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bivalirudin
Arm Type
Active Comparator
Arm Description
Anticoagulation during percutaneous coronary intervention
Arm Title
Unfractionated Heparin
Arm Type
Active Comparator
Arm Description
Anticoagulation during percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Angiomax
Intervention Description
Anticoagulation during percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Anticoagulation during percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Bleeding events
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
MACE
Description
Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Jeremias, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention
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