NCT00773006

Brief Summary

Advances in mechanical intervention (PCI) and anticoagulation therapy have been the cornerstone of treatment of patients with coronary artery disease. However, the large diversity of approaches to anticoagulation during PCI introduces gaps in knowledge regarding management of cardiac patients. As such, we have initiated a national PCI registry to elucidate anticoagulant choice, dosing strategies, case selection dynamics, and clinical outcomes in the Canadian health care environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
747

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

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

First Submitted

Initial submission to the registry

January 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

2.3 years

First QC Date

January 28, 2008

Last Update Submit

October 3, 2011

Conditions

Keywords

coronary artery diseasepercutaneous coronary interventionanticoagulation

Outcome Measures

Primary Outcomes (1)

  • Description of anticoagulant management during PCI and current practices of participating centres will be undertaken

    in-hospital

Secondary Outcomes (3)

  • In-hospital safety outcomes including - major, minor bleeding, requirement for transfusion, death, myocardial infarction (or re-MI), myocardial ischemia requiring urgent revascularization, and major bleeding

    in-hospital

  • In-hospital angiographic complications: no reflow, thrombus, occlusion of collateral branches, distal embolism, coronary dissection, acute closure of the culprit vessel

    in-hospital

  • PCI-related resources utilization during the study period, including cost of PCI and its treatment (e.g. duration of hospital stay, drug costs, costs related to bleeding such as transfusions)

    in-hospital

Study Arms (3)

A

Stable/elective PCI patients

B

NSTEMI PCI patients

C

STEMI PCI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UA, STEMI and NSTEMI ACS patients treated prior to PCI with LMWH and/or patients treated with LMWH during PCI i.e. in catheterization laboratory.

You may qualify if:

  • or more years of age.
  • Undergoing PCI during treatment with LMWH
  • Provision of written and informed consent

You may not qualify if:

  • Language, medical, or psychiatric barriers that preclude understanding of informed consent process.
  • Patients in which the site investigator is unable to comply with completion of study documentation following PCI, i.e. patients with planned transfer to another hospital not participating in the registry.
  • Enrollment in a clinical trial involving another anticoagulant agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2008

First Posted

October 16, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2010

Study Completion

September 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations