Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention (STATUS PCI)
This study is currently recruiting participants.
Verified October 2011 by Stony Brook University
Sponsor:
Stony Brook University
Information provided by (Responsible Party):
Allen Jeremias, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01464671
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Bivalirudin Drug: Heparin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention |
Resource links provided by NLM:
Further study details as provided by Stony Brook University:
Primary Outcome Measures:
- Bleeding events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
| Estimated Enrollment: | 776 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464671
Contacts
| Contact: Allen Jeremias, MD | 631-444-1393 | allen.jeremias@stonybrook.edu |
Locations
| United States, New York | |
| Stony Brook University Medical Center | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Allen Jeremias, MD 631-444-1393 allen.jeremias@stonybrook.edu | |
Sponsors and Collaborators
Stony Brook University
Investigators
| Principal Investigator: | Allen Jeremias, MD | Stony Brook University |
More Information
No publications provided
| Responsible Party: | Allen Jeremias, Associate Professor, Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT01464671 History of Changes |
| Other Study ID Numbers: | 119778 (IRB ID) |
| Study First Received: | October 31, 2011 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013