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

Primary Purpose

Saphenous Vein Graft Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aspirin
Ticagrelor
Sponsored by
Boca Raton Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Saphenous Vein Graft Disease focused on measuring Saphenous vein graft disease, Coronary artery bypass graft surgery, Antiplatelet therapy, Coronary artery disease, Secondary prevention, Graft patency

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boca Raton Regional Hospital
  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aspirin

Ticagrelor

Arm Description

One aspirin 81 mg capsule 2 times per day

One ticagrelor 90 mg capsule 2 times per day

Outcomes

Primary Outcome Measures

Saphenous Vein Graft Occlusion
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.

Secondary Outcome Measures

Saphenous Vein Graft Stenosis
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.

Full Information

First Posted
January 30, 2014
Last Updated
August 19, 2022
Sponsor
Boca Raton Regional Hospital
Collaborators
AstraZeneca, Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02053909
Brief Title
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
Acronym
TARGET
Official Title
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boca Raton Regional Hospital
Collaborators
AstraZeneca, Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Saphenous Vein Graft Disease
Keywords
Saphenous vein graft disease, Coronary artery bypass graft surgery, Antiplatelet therapy, Coronary artery disease, Secondary prevention, Graft patency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
One aspirin 81 mg capsule 2 times per day
Arm Title
Ticagrelor
Arm Type
Active Comparator
Arm Description
One ticagrelor 90 mg capsule 2 times per day
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brillinta
Primary Outcome Measure Information:
Title
Saphenous Vein Graft Occlusion
Description
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.
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Saphenous Vein Graft Stenosis
Description
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.
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female and/or male patients aged 18-90 years Patients undergoing first-time CABG with at least 1 saphenous vein graft, irrespective of concurrent valve surgery Exclusion Criteria: Inability to provide informed consent Pregnancy or seeking pregnancy Patients undergoing redo-CABG Serum creatinine >1.8 mg/dL (need for contrast with CT coronary angiogram) Hypersensitivity or allergy to aspirin or ticagrelor Anticipated need for postoperative anticoagulation with coumadin, dabigatran or rivaroxaban (mechanical valve, chronic atrial fibrillation, DVT/PE) History of gastrointestinal hemorrhage Active pathological bleeding History of intracranial hemorrhage Severe hepatic impairment Current or anticipated use of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazadone, ritonavir, and atazanavir)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Kulik, MD MPH
Organizational Affiliation
Boca Raton Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29551675
Citation
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.
Results Reference
derived

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Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

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