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

This study is currently recruiting participants.
Verified July 2016 by Dr. Alexander Kulik, Boca Raton Regional Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02053909
First Posted: February 4, 2014
Last Update Posted: July 20, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
AstraZeneca
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Dr. Alexander Kulik, Boca Raton Regional Hospital
  Purpose
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 Intervention Phase
Saphenous Vein Graft Disease Drug: Aspirin Drug: Ticagrelor Phase 4

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Dr. Alexander Kulik, Boca Raton Regional Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: September 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brillinta

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT02053909


Contacts
Contact: Alexander Kulik, MD MPH 561-955-6300 alex_kulik@yahoo.com

Locations
United States, Florida
Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Alexander Kulik, MD MPH       alex_kulik@yahoo.com   
Principal Investigator: Alexander Kulik, MD MPH         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada
Contact: Marc Ruel, MD MPH       mruel@ottawaheart.ca   
Principal Investigator: Marc Ruel, MD MPH         
Sponsors and Collaborators
Boca Raton Regional Hospital
AstraZeneca
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Alexander Kulik, MD MPH Boca Raton Regional Hospital
  More Information

Responsible Party: Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital
ClinicalTrials.gov Identifier: NCT02053909     History of Changes
Other Study ID Numbers: Brilinta ISSBRIL0220
First Submitted: January 30, 2014
First Posted: February 4, 2014
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Dr. Alexander Kulik, Boca Raton Regional Hospital:
Saphenous vein graft disease
Coronary artery bypass graft surgery
Antiplatelet therapy
Coronary artery disease
Secondary prevention
Graft patency

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Embolism and Thrombosis
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents