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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Cardiology Research UBC
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Dr. Jacqueline Saw, Interventional Cardiology Research
ClinicalTrials.gov Identifier:
NCT01373411
First received: June 13, 2011
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: ticagrelor
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)

Resource links provided by NLM:


Further study details as provided by Cardiology Research UBC:

Primary Outcome Measures:
  • Composite of all-cause mortality, MI, stroke, or repeat revascularization [ Time Frame: within one year following CABG ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improving graft patency [ Time Frame: 3 months post-CABG ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 244
Study Start Date: September 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373411

Contacts
Contact: Jackie Saw, MD, FRCPC jsaw@interchange.ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Rebecca Fox, PA, MSc       rebecca.fox@ubc.ca   
Sub-Investigator: Jian Ye         
Sub-Investigator: Richard Cook         
Sub-Investigator: John Mayo, MD, FRCPC         
Sub-Investigator: John Cairns         
Sub-Investigator: Guy Fradet         
Sub-Investigator: John GB Mancini, MD         
Sub-Investigator: Peter Skarsgard         
Principal Investigator: Jackie Saw, MD, FRCPC         
Sub-Investigator: Victoria Bernstein         
Sponsors and Collaborators
Cardiology Research UBC
University of British Columbia
Investigators
Principal Investigator: Jackie Saw, BSc, MD, FRCPC, FACC, FSCAI University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Jacqueline Saw, Principal Investigator, Interventional Cardiology Research
ClinicalTrials.gov Identifier: NCT01373411     History of Changes
Other Study ID Numbers: H10-01452
Study First Received: June 13, 2011
Last Updated: March 26, 2013
Health Authority: Canada: Health Canada

Keywords provided by Cardiology Research UBC:
CABG
Ticagrelor
Coronary Artery Bypass Surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014