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Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

NCT01464671 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-11-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bivalirudin

Anticoagulation during percutaneous coronary intervention

DRUG

Heparin

Anticoagulation during percutaneous coronary intervention

Sponsors & Collaborators

Principal Investigators

  • Allen Jeremias, MD · Stony Brook University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464671 on ClinicalTrials.gov