Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

Saphenous Vein Graft Disease Clinical Trial

— TARGET  

Official title:

Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053909
• Other study ID #: Brilinta ISSBRIL0220
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: August 2021

Study information

• Verified date: August 2022
• Source: Boca Raton Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Saphenous Vein Graft Disease
• Thrombosis

Intervention

Drug:
• Aspirin

• Ticagrelor

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
United States	Boca Raton Regional Hospital	Boca Raton	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Boca Raton Regional Hospital	AstraZeneca, Ottawa Heart Institute Research Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year after surgery