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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
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
  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:

  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
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

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 October 19, 2014