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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boca Raton Regional Hospital
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Alexander Kulik, Boca Raton Regional Hospital
ClinicalTrials.gov Identifier:
NCT02053909
First received: January 30, 2014
Last updated: September 24, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Boca Raton Regional Hospital:

Primary Outcome Measures:
  • Saphenous vein graft occlusion [ Time Frame: 1 year and 2 years after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: September 2018
Estimated Primary Completion Date: September 2018 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: 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
Principal Investigator: Alexander Kulik, MD MPH         
Sponsors and Collaborators
Boca Raton Regional Hospital
AstraZeneca
Investigators
Principal Investigator: Alexander Kulik, MD MPH Boca Raton Regional Hospital
  More Information

No publications provided

Responsible Party: Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital
ClinicalTrials.gov Identifier: NCT02053909     History of Changes
Other Study ID Numbers: Brilinta ISSBRIL0220
Study First Received: January 30, 2014
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014