NCT01373411

Brief Summary

Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2011

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2013

Enrollment Period

3.5 years

First QC Date

June 13, 2011

Last Update Submit

March 24, 2015

Conditions

Coronary Artery Disease

Keywords

CABGTicagrelorCoronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality, MI, stroke, or repeat revascularization

    within one year following CABG

Secondary Outcomes (1)

  • Improving graft patency

    3 months post-CABG

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo twice daily. Study drug will be started within 48 hours of CABG.

Drug: Placebo

ticagrelor 90 mg

ACTIVE COMPARATOR

Taken twice daily. Study drug will be started within 48 hours of CABG.

Drug: ticagrelor

Interventions

ticagrelorDRUG

ticagrelor 90 mg BID for 90 days

Also known as: Brilinta
ticagrelor 90 mg
PlaceboDRUG

Placebo 1 pill BID for 90 days

Placebo

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG
  • Females of child-bearing age must have a negative pregnancy test at enrollment

You may not qualify if:

  • Patients undergoing combined valve or aortic surgeries
  • Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
  • Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
  • Patients with active bleeding or history of bleeding diathesis
  • Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
  • Patients with severe liver disease (e.g. ascites or signs of coagulopathy)
  • Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker
  • Patients with end-stage renal failure requiring dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

  • Saw J, Wong GC, Mayo J, Bernstein V, Mancini GB, Ye J, Skarsgard P, Starovoytov A, Cairns J. Ticagrelor and aspirin for the prevention of cardiovascular events after coronary artery bypass graft surgery. Heart. 2016 May 15;102(10):763-9. doi: 10.1136/heartjnl-2015-308691. Epub 2016 Feb 18.

    PMID: 26891756DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Jackie Saw, BSc, MD, FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 15, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 26, 2015

Record last verified: 2013-03

Locations

CA(1)