Coronary Artery DiseasePhase 4EASY-B2BNCT01084993
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
A Phase 4 study testing Bivalirudin and Heparin in people with Coronary Artery Disease, run by Laval University at 1 site in Canada.
Trial summary
RATIONALE: Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach. Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Bivalirudin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Jan 2019
- Phase
- Phase 4
- 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
Who may be able to join
- At least two of the following additional criteria
- At least 70 yrs old
- Female gender
- Diabetes
- Creatinine clearance <60mL/min
- History of gastro-intestinal or other organ bleeding
- Baseline anemia
- Current treatment with glycoproteins IIb-IIIa inhibitors
Who cannot join
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
- Concurrent participation in other investigational study
- Femoral sheath (artery)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Quebec Heart-Lung Institute
Québec, Quebec, G1V 4G5
Michele Jadin, MSc, 418-6568711 ext. 3007, michele.jadin@crhl.ulaval.ca
Olivier F Bertrand, MD, PhD
About this study
Official title: EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study
RATIONALE:
Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach.
Read more
Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding.
Peri-procedural anemia is also an independent predictor of mortality and MACE.
With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding.
In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa.
HYPOTHESES:
In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.
In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.
Read the detailed description
OBJECTIVES:
The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.
- Conditions
- Coronary Artery Disease
- Being tested
- Bivalirudin, Heparin
- Keywords
- Coronary artery stenting, transradial, intracoronary
- 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.
BivalirudinDrug
Also called Angiomax
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
HeparinDrug
70 U/kg
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Active comparator | Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h Receives: Drug: Bivalirudin |
| Heparin | Active comparator | 70 U/kg or standard practice Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding and Mace
The primary end-points will be 1) the incidence of major bleeding (Replace-2 criteria) at hospital discharge and 2) the incidence of 24h post-PCI anemia (WHO criteria)
Measured: 24h post-PCI and Discharge
Secondary outcomes (1)
EFFICACY and SAFETY PARAMETERS
The composite of death, MI (def 1 : Tn-t > 0.1 and def 2 : CK-MB > 30μg/l), urgent revascularization and major bleeding at 30 days post-PCI.
The incidence of ARC-defined stent thrombosis at 30 days. The incidence of access-site hematoma according to EASY scale. The incidence of radial artery occlusion at hospital discharge according to echo-doppler evaluation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2018 (estimated)
- Study completionJan 2019 (estimated)
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 Laval UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F Bertrand, MD, PhD, Principal investigator, Fondation IUCPQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084993
- Sponsor's protocol ID
- EASY-B2B
- Acronym
- EASY-B2B
- Status last verified
- Jan 2018
- First submitted
- 9 Mar 2010
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study
- ClinicalTrials.gov ID
- NCT01084993
- Acronym / sponsor ID
- EASY-B2B / EASY-B2B
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery stenting, transradial, intracoronary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 11 Mar 2010 (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.
RATIONALE:
Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach.
Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding.
Peri-procedural anemia is also an independent predictor of mortality and MACE.
With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding.
In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa.
HYPOTHESES:
In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.
In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.
Detailed description
OBJECTIVES:
The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Active comparator | Drug: BivalirudinStandard practice: 0.75mg/kg + infusion 1.75mg/kg/h |
| Heparin | Active comparator | Drug: Heparin70 U/kg or standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least two of the following additional criteria
- At least 70 yrs old
- Female gender
- Diabetes
- Creatinine clearance <60mL/min
Key exclusion criteria (3 listed)
- Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
- Concurrent participation in other investigational study
- Femoral sheath (artery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BivalirudinAlso: AngiomaxStandard practice: 0.75mg/kg + infusion 1.75mg/kg/h | Drug | Bivalirudin |
| Heparin70 U/kg | Drug | Heparin |
Primary outcome
Major bleeding and Mace
Time frame: 24h post-PCI and Discharge
The primary end-points will be 1) the incidence of major bleeding (Replace-2 criteria) at hospital discharge and 2) the incidence of 24h post-PCI anemia (WHO criteria)
1 secondary outcome
EFFICACY and SAFETY PARAMETERS
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
Olivier F Bertrand, MD, PhD principal investigator
Fondation IUCPQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin and Heparin in people with Coronary Artery Disease, run by Laval University 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 8 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: status not confirmed, as of the sponsor's last update on 31 Jan 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier F Bertrand, MD, PhD (418-656-8711, olivier.bertrand@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding and Mace (time frame: 24h post-PCI and Discharge). 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 31 Jan 2018.