Canadian Anticoagulant PCI Registry - Full Text View

Sponsored by:	University of Alberta
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00773006

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

MedlinePlus related topics: Blood Thinners Coronary Artery Disease

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	February 2008

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:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773006

Contacts

Contact: Robert C Welsh, MD

7804073613

robert.welsh@capitalhealth.ca

Locations

Canada, Alberta
University of Alberta	Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Robert C. Welsh, MD 780-407-3613 rwelsh@cha.ab.ca

Sponsors and Collaborators

University of Alberta

More Information

Responsible Party:	University of Alberta ( Robert C. Welsh - Chair executive committee )
Study ID Numbers:	CAPCIR02474
Study First Received:	January 28, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773006
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Alberta:

coronary artery disease
percutaneous coronary intervention
anticoagulation

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009