Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Bivalirudin
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bivalirudin<br>Anticoagulation during percutaneous coronary intervention | Drug: Bivalirudin<br>* Anticoagulation during percutaneous coronary intervention<br>* Other names: Angiomax;Drug: Heparin<br>* Anticoagulation during percutaneous coronary intervention<br>|
| Active Comparator: Unfractionated Heparin<br>Anticoagulation during percutaneous coronary intervention | Drug: Heparin<br>* Anticoagulation during percutaneous coronary intervention<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Stable Angina, Percutaneous Coronary Intervention