TARGET: Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

Sponsor
Boca Raton Regional Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02053909
Collaborator
AstraZeneca (Industry), Ottawa Heart Institute Research Corporation (Other)
250
2
2
83
125
1.5

Study Details

Study Description

Brief Summary

Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more pronounced platelet inhibition, and may substantially improve graft patency following CABG compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on saphenous vein graft patency following CABG. In this context, the investigators seek to compare vein graft patency between patients randomized to receive aspirin therapy, the current standard of care, or ticagrelor treatment, starting in the early postoperative period, and continuing for 2 years after CABG.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This clinical trial will be a randomized double-blind study focusing on ticagrelor antiplatelet therapy as a means of improving vein graft patency after CABG. Patients will be eligible if they have received at least 1 vein bypass graft at time of surgery. Patients will be randomized to receive either aspirin 81 mg bid or ticagrelor 90 mg bid. The aspirin and ticagrelor medications will be prepared in blinded capsules. Patients recovering from surgery will be eligible for study randomization within the first 5 postoperative days. Treatment will continue for 1 year, at which time patients will undergo a CT coronary angiogram to assess graft patency. Patients will then be invited to continue participating in the trial for 1 more year, and a repeat CT coronary angiogram will be performed at the 2 year postoperative time-point.

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass?
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Aspirin

One aspirin 81 mg capsule 2 times per day

Drug: Aspirin

Active Comparator: Ticagrelor

One ticagrelor 90 mg capsule 2 times per day

Drug: Ticagrelor
Other Names:
  • Brillinta
  • Outcome Measures

    Primary Outcome Measures

    1. Saphenous vein graft occlusion [1 year and 2 years after surgery]

      The primary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft occlusion 1 year after surgery, as assessed by computed tomography (CT) coronary angiography, as well as 2 years after surgery via study extension.

    Secondary Outcome Measures

    1. Saphenous vein graft stenosis [1 year and 2 years after surgery]

      The secondary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft stenosis, defined as >50% narrowing of the graft, 1 year after surgery, as assessed by computed tomography (CT) coronary angiography, as well as 2 years after surgery via study extension.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Provision of informed consent prior to any study specific procedures

    2. Female and/or male patients aged 18-90 years

    3. Patients undergoing first-time CABG with at least 1 saphenous vein graft, irrespective of concurrent valve surgery

    Exclusion Criteria:
    1. Inability to provide informed consent

    2. Pregnancy or seeking pregnancy

    3. Patients undergoing redo-CABG

    4. Serum creatinine >1.8 mg/dL (need for contrast with CT coronary angiogram)

    5. Hypersensitivity or allergy to aspirin or ticagrelor

    6. Anticipated need for postoperative anticoagulation with coumadin, dabigatran or rivaroxaban (mechanical valve, chronic atrial fibrillation, DVT/PE)

    7. History of gastrointestinal hemorrhage

    8. Active pathological bleeding

    9. History of intracranial hemorrhage

    10. Severe hepatic impairment

    11. Current or anticipated use of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazadone, ritonavir, and atazanavir)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boca Raton Regional Hospital Boca Raton Florida United States 33486
    2 University of Ottawa Heart Institute Ottawa Ontario Canada

    Sponsors and Collaborators

    • Boca Raton Regional Hospital
    • AstraZeneca
    • Ottawa Heart Institute Research Corporation

    Investigators

    • Principal Investigator: Alexander Kulik, MD MPH, Boca Raton Regional Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital
    ClinicalTrials.gov Identifier:
    NCT02053909
    Other Study ID Numbers:
    • Brilinta ISSBRIL0220
    First Posted:
    Feb 4, 2014
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 17, 2022