NCT00391326

Brief Summary

The purpose of this study is to describe the efficacy and safety of prehospital administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial infarction redirected for primary angioplasty bypassing local hospitals, immediately after the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

October 19, 2006

Last Update Submit

May 20, 2008

Conditions

Acute Myocardial Infarction

Keywords

BivalirudinHeparinBleedingTIMI flowSTEMI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with STEMI transferred directly to primary PCI based og transmission of a prehospital ECG

You may qualify if:

  • ST elevation acute myocardial infarction patients redirected for primary angioplasty
  • Symptoms less than 12 hours

You may not qualify if:

  • Contraindications against primary angioplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

H:S Lægeambulance

Copenhagen, V, 1553, Denmark

Location

Rigshospitalet

Copenhagen, Ø, 2100, Denmark

Location

MeSH Terms

Conditions

HemorrhageST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Peter Clemmsensen, MD. phD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 23, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations

DK(2)