Canadian Anticoagulant Percutaneous Coronary Intervention Registry

Coronary Artery Disease Clinical Trial

— CAPCIR  

Official title:

Canadian Prospective, Observational Study on the Use of LMWH in the Setting of Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773006
• Other study ID #: CAPCIR02474
• Status: Completed
• Phase: N/A
• First received: January 28, 2008
• Last updated: October 3, 2011
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of anticoagulant management during PCI and current practices of participating centres will be undertaken		in-hospital	No
Secondary	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	Yes
Secondary	In-hospital angiographic complications: no reflow, thrombus, occlusion of collateral branches, distal embolism, coronary dissection, acute closure of the culprit vessel		in-hospital	Yes
Secondary	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	No