Canadian Anticoagulant Percutaneous Coronary Intervention Registry (CAPCIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Welsh, University of Alberta
ClinicalTrials.gov Identifier:
NCT00773006
First received: January 28, 2008
Last updated: October 3, 2011
Last verified: October 2011
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773006

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

No publications provided

Responsible Party: Robert Welsh, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00773006     History of Changes
Other Study ID Numbers: CAPCIR02474
Study First Received: January 28, 2008
Last Updated: October 3, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014