Coronary Artery DiseaseCAPCIRNCT00773006
Canadian Anticoagulant Percutaneous Coronary Intervention Registry
An observational study of Coronary Artery Disease, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 747 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 or more years of age.
- Undergoing PCI during treatment with LMWH
- Provision of written and informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian Prospective, Observational Study on the Use of LMWH in the Setting of Percutaneous Coronary Intervention
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.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, percutaneous coronary intervention, anticoagulation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Stable/elective PCI patients | |
| B | NSTEMI PCI patients | |
| C | STEMI PCI patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of anticoagulant management during PCI and current practices of participating centres will be undertaken
Measured: 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
Measured: in-hospital
In-hospital angiographic complications: no reflow, thrombus, occlusion of collateral branches, distal embolism, coronary dissection, acute closure of the culprit vessel
Measured: 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)
Measured: in-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Welsh, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773006
- Sponsor's protocol ID
- CAPCIR02474
- Acronym
- CAPCIR
- Status last verified
- Oct 2011
- First submitted
- 28 Jan 2008
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Prospective, Observational Study on the Use of LMWH in the Setting of Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00773006
- Acronym / sponsor ID
- CAPCIR / CAPCIR02474
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, percutaneous coronary intervention, anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | –Stable/elective PCI patients |
| B | – | –NSTEMI PCI patients |
| C | – | –STEMI PCI patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 or more years of age.
- Undergoing PCI during treatment with LMWH
- Provision of written and informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of anticoagulant management during PCI and current practices of participating centres will be undertaken
Time frame: in-hospital
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of anticoagulant management during PCI and current practices of participating centres will be undertaken (time frame: in-hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.