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Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET)

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ClinicalTrials.gov Identifier: NCT02053909
Recruitment Status : Recruiting
First Posted : February 4, 2014
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
AstraZeneca
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Dr. Alexander Kulik, Boca Raton Regional Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE February 4, 2014
Last Update Posted Date July 9, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2014)
Saphenous vein graft occlusion [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2014)
Saphenous vein graft stenosis [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
Official Title  ICMJE Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass?
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Saphenous Vein Graft Disease
Intervention  ICMJE
  • Drug: Aspirin
  • Drug: Ticagrelor
    Other Name: Brillinta
Study Arms  ICMJE
  • Active Comparator: Aspirin
    One aspirin 81 mg capsule 2 times per day
    Intervention: Drug: Aspirin
  • Active Comparator: Ticagrelor
    One ticagrelor 90 mg capsule 2 times per day
    Intervention: Drug: Ticagrelor
Publications * Kulik A, Abreu AM, Boronat V, Kouchoukos NT, Ruel M. Impact of ticagrelor versus aspirin on graft patency after CABG: Rationale and design of the TARGET (ticagrelor antiplatelet therapy to reduce graft events and thrombosis) randomized controlled trial (NCT02053909). Contemp Clin Trials. 2018 May;68:45-51. doi: 10.1016/j.cct.2018.03.008. Epub 2018 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2014)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexander Kulik, MD MPH 561-955-6300 alex_kulik@yahoo.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02053909
Other Study ID Numbers  ICMJE Brilinta ISSBRIL0220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alexander Kulik, Boca Raton Regional Hospital
Study Sponsor  ICMJE Boca Raton Regional Hospital
Collaborators  ICMJE
  • AstraZeneca
  • Ottawa Heart Institute Research Corporation
Investigators  ICMJE
Principal Investigator: Alexander Kulik, MD MPH Boca Raton Regional Hospital
PRS Account Boca Raton Regional Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP