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

This study has been terminated.

(DSMB halted the study early due to futility. There were no safety concerns.)

Sponsor:

Information provided by (Responsible Party):

Allen Jeremias, Stony Brook University

ClinicalTrials.gov Identifier:

NCT01464671

First received: October 31, 2011

Last updated: November 19, 2014

Last verified: November 2014

History of Changes

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:

MedlinePlus related topics: Angina Blood Thinners Coronary Artery Disease

Drug Information available for: Bivalirudin

U.S. FDA Resources

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).


Enrollment:	260
Study Start Date:	July 2009
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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 19, 2014
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 Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016

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