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Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (TAP-CABG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01373411
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : March 26, 2015
University of British Columbia
Information provided by (Responsible Party):
Dr. Jacqueline Saw, Cardiology Research UBC

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: ticagrelor Drug: Placebo Phase 4

Detailed Description:

Patients will be screened for eligibility pre-CABG, and informed consent signed before randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine practice. Study medication will be started within 48 hours after CABG if there are no contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year post-CABG. Other cardiac medications will be at the discretion of the treating physicians as per standard practice.

Patients will be followed daily during their hospital stay. Outpatient visits will be scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.

CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter if there are disagreements. If no consensus could be reached among the 3 interpreters, the graft will be deemed not analyzable, or be subject to invasive coronary angiography for definitive assessment if clinically indicated.

The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat revascularization within 1 year following CABG. Secondary endpoints include the individual endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)
Study Start Date : September 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo twice daily. Study drug will be started within 48 hours of CABG.
Drug: Placebo
Placebo 1 pill BID for 90 days

Active Comparator: ticagrelor 90 mg
Taken twice daily. Study drug will be started within 48 hours of CABG.
Drug: ticagrelor
ticagrelor 90 mg BID for 90 days
Other Name: Brilinta

Primary Outcome Measures :
  1. Composite of all-cause mortality, MI, stroke, or repeat revascularization [ Time Frame: within one year following CABG ]

Secondary Outcome Measures :
  1. Improving graft patency [ Time Frame: 3 months post-CABG ]
    The secondary study objective is to evaluate if the combination of ticagrelor and aspirin administered after CABG will improve graft patency at 3 months, compared with aspirin alone. This will be monitored and assessing in the CT angiography substudy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients undergoing combined valve or aortic surgeries
  2. Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
  3. Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
  4. Patients with active bleeding or history of bleeding diathesis
  5. Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
  6. Patients with severe liver disease (e.g. ascites or signs of coagulopathy)
  7. Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker
  8. Patients with end-stage renal failure requiring dialysis
  9. For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01373411

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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Cardiology Research UBC
University of British Columbia
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Principal Investigator: Jackie Saw, BSc, MD, FRCPC University of British Columbia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Jacqueline Saw, Principal Investigator, Cardiology Research UBC Identifier: NCT01373411    
Other Study ID Numbers: H10-01452
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2013
Keywords provided by Dr. Jacqueline Saw, Cardiology Research UBC:
Coronary Artery Bypass Surgery
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs