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

STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Bivalirudin; Drug: Heparin

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 Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bivalirudin; Anticoagulation during percutaneous coronary intervention	Drug: Bivalirudin; Anticoagulation during percutaneous coronary intervention; Other Names: Angiomax; Drug: Heparin; Anticoagulation during percutaneous coronary intervention
Active Comparator: Unfractionated Heparin; Anticoagulation during percutaneous coronary intervention	Drug: Heparin; Anticoagulation during percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Allen Jeremias, MD, Stony Brook University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Stable Angina; Percutaneous Coronary Intervention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin
• Other Study ID Numbers: 119778 (IRB ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No