NCT00439855

Brief Summary

Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,100

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
Last Updated

February 26, 2007

Status Verified

February 1, 2007

First QC Date

February 23, 2007

Last Update Submit

February 23, 2007

Conditions

Coronary Artery Disease

Keywords

Enoxaparin, heparin, hemorrhages

Outcome Measures

Primary Outcomes (1)

  • Quadruple endpoint: death, MI, urgent TVR, major bleeding

Secondary Outcomes (1)

  • major bleeding, minor bleeding, thrombocytopenia

Interventions

Enoxaparin i.v.DRUG
unfractionated heparinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PCI for stable ischemia or ACS

You may not qualify if:

  • Cardiogenic shock,
  • Pretreatment with study drugs,
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology Triemli Hospital Zurich

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • osmund bertel, MD

    Division of Cardiology Triemli Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

September 1, 2003

Study Completion

February 1, 2006

Last Updated

February 26, 2007

Record last verified: 2007-02

Locations

CH(1)