NCT01084993

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

8.5 years

First QC Date

March 9, 2010

Last Update Submit

January 29, 2018

Conditions

Coronary Artery Disease

Keywords

Coronary artery stenting, transradial, intracoronary

Outcome Measures

Primary Outcomes (1)

  • 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)

    24h post-PCI and Discharge

Secondary Outcomes (1)

  • EFFICACY and SAFETY PARAMETERS

    30 days

Study Arms (2)

Bivalirudin

ACTIVE COMPARATOR

Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h

Drug: Bivalirudin

Heparin

ACTIVE COMPARATOR

70 U/kg or standard practice

Drug: Heparin

Interventions

BivalirudinDRUG

Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h

Also known as: Angiomax
Bivalirudin
HeparinDRUG

70 U/kg

Heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
  • Concurrent participation in other investigational study
  • Femoral sheath (artery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quebec Heart-Lung Institute

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

bivalirudinHeparin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Olivier F Bertrand, MD, PhD

    Fondation IUCPQ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier F Bertrand, MD, PhD

CONTACT

418-656-8711olivier.bertrand@criucpq.ulaval.ca

Michele Jadin, MSc

CONTACT

418-656-8711michele.jadin@criucpq.ulaval.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 11, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2018

Study Completion

January 1, 2019

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

CA(1)