Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

NCT02053909 | Completed Phase 4 Results

• 1 other identifier: Brilinta ISSBRIL0220
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 2

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.

Conditions

Saphenous Vein Graft Disease

Keywords

Saphenous vein graft disease; Coronary artery bypass graft surgery; Antiplatelet therapy; Coronary artery disease; Secondary prevention; Graft patency

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year after surgery

Secondary Outcomes (1)

• Saphenous Vein Graft Stenosis

  1 year after surgery

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

One aspirin 81 mg capsule 2 times per day

Drug: Aspirin

Ticagrelor

ACTIVE COMPARATOR

One ticagrelor 90 mg capsule 2 times per day

Drug: Ticagrelor

Interventions

Aspirin DRUG

Aspirin

Ticagrelor DRUG

Also known as: Brillinta

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boca Raton Regional Hospital: lead
• AstraZeneca: collaborator
• Ottawa Heart Institute Research Corporation: collaborator

Study Sites (2)

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 29551675 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Alexander Kulik
• Organization: Boca Raton Regional Hospital

alex_kulik@yahoo.com

561-955-6300

Study Officials

• Alexander Kulik, MD MPH

  Boca Raton Regional Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgeon

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 4, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: September 14, 2022
• Results First Posted: September 14, 2022

Record last verified: 2022-08

Locations

CA (1); US (1)