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

• Sponsor: Stony Brook University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01464671
• Collaborator: (none)
• Enrollment: 260
• Location: 1
• Arms: 2
• Duration (Months): 62
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Bivalirudin; Drug: Heparin	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bleeding events [30 days]

   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

1. MACE [1 year]

   Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allen Jeremias, Associate Professor, Stony Brook University
• ClinicalTrials.gov Identifier: NCT01464671
• Other Study ID Numbers: 119778 (IRB ID)
• First Posted: Nov 3, 2011
• Last Update Posted: Nov 20, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Allen Jeremias, Associate Professor, Stony Brook University: Coronary Artery Disease; Stable Angina; Percutaneous Coronary Intervention
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heparin; Bivalirudin

Study Results

No Results Posted as of Nov 20, 2014