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Canadian Anticoagulant Percutaneous Coronary Intervention Registry (CAPCIR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773006
First Posted: October 16, 2008
Last Update Posted: October 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Welsh, University of Alberta
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Prospective, Observational Study on the Use of LMWH in the Setting of Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Robert Welsh, University of Alberta:

Primary Outcome Measures:
  • Description of anticoagulant management during PCI and current practices of participating centres will be undertaken [ Time Frame: in-hospital ]

Secondary Outcome Measures:
  • 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 [ Time Frame: in-hospital ]
  • In-hospital angiographic complications: no reflow, thrombus, occlusion of collateral branches, distal embolism, coronary dissection, acute closure of the culprit vessel [ Time Frame: 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) [ Time Frame: in-hospital ]

Enrollment: 747
Study Start Date: February 2008
Study Completion Date: September 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Stable/elective PCI patients
B
NSTEMI PCI patients
C
STEMI PCI patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  1. 18 or more years of age.
  2. Undergoing PCI during treatment with LMWH
  3. Provision of written and informed consent

Exclusion Criteria:

  1. Language, medical, or psychiatric barriers that preclude understanding of informed consent process.
  2. 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.
  3. Enrollment in a clinical trial involving another anticoagulant agent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773006


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
  More Information

Responsible Party: Robert Welsh, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00773006     History of Changes
Other Study ID Numbers: CAPCIR02474
First Submitted: January 28, 2008
First Posted: October 16, 2008
Last Update Posted: October 5, 2011
Last Verified: October 2011

Keywords provided by Robert Welsh, University of Alberta:
coronary artery disease
percutaneous coronary intervention
anticoagulation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases