Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

— STATUS PCI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01464671
• Other study ID #: 119778 (IRB ID)
• Status: Terminated
• Phase: Phase 4
• First received: October 31, 2011
• Last updated: November 19, 2014
• Start date: July 2009
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 260
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Bivalirudin
Anticoagulation during percutaneous coronary intervention
• Heparin
Anticoagulation during percutaneous coronary intervention

Locations

Country	Name	City	State
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes