NCT01464671

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

5.2 years

First QC Date

October 31, 2011

Last Update Submit

November 19, 2014

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseStable AnginaPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • MACE

    1 year

Study Arms (2)

Bivalirudin

ACTIVE COMPARATOR

Anticoagulation during percutaneous coronary intervention

Drug: BivalirudinDrug: Heparin

Unfractionated Heparin

ACTIVE COMPARATOR

Anticoagulation during percutaneous coronary intervention

Drug: Heparin

Interventions

BivalirudinDRUG

Anticoagulation during percutaneous coronary intervention

Also known as: Angiomax
Bivalirudin
HeparinDRUG

Anticoagulation during percutaneous coronary intervention

BivalirudinUnfractionated Heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, Stable

Interventions

bivalirudinHeparin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Allen Jeremias, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 3, 2011

Study Start

July 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

US(1)