Saphenous Vein Graft DiseasePhase 4TARGETNCT02053909
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
A Phase 4 study testing Aspirin and Ticagrelor in people with Saphenous Vein Graft Disease, run by Boca Raton Regional Hospital at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Saphenous Vein Graft Disease
- What is being tested?
- Aspirin and Ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2014to Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
About this study
Official title: Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass?
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.
Read the 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.
- Conditions
- Saphenous Vein Graft Disease
- Being tested
- Aspirin, Ticagrelor
- Keywords
- Saphenous vein graft disease, Coronary artery bypass graft surgery, Antiplatelet therapy, Coronary artery disease, Secondary prevention, Graft patency
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
TicagrelorDrug
Also called Brillinta
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | One aspirin 81 mg capsule 2 times per day Receives: Drug: Aspirin |
| Ticagrelor | Active comparator | One ticagrelor 90 mg capsule 2 times per day Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after surgery
Secondary outcomes (1)
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.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2020
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Saphenous Vein Graft DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boca Raton Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Ottawa Heart Institute Research Corporation
- Responsible party
- Principal investigator, Dr. Alexander Kulik, Boca Raton Regional Hospital
- Investigators
- Alexander Kulik, MD MPH, Principal investigator, Boca Raton Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053909
- Sponsor's protocol ID
- Brilinta ISSBRIL0220
- Acronym
- TARGET
- Status last verified
- Aug 2022
- First submitted
- 30 Jan 2014
- Last updated
- 14 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29551675
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass?
- ClinicalTrials.gov ID
- NCT02053909
- Acronym / sponsor ID
- TARGET / Brilinta ISSBRIL0220
- Conditions
- Saphenous Vein Graft Disease
- Keywords
- Saphenous vein graft disease, Coronary artery bypass graft surgery, Antiplatelet therapy, Coronary artery disease, Secondary prevention, Graft patency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boca Raton Regional HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca, Ottawa Heart Institute Research Corporation
- Study start
- Sep 2014
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 14 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: AspirinOne aspirin 81 mg capsule 2 times per day |
| Ticagrelor | Active comparator | Drug: TicagrelorOne ticagrelor 90 mg capsule 2 times per day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin | Drug | Aspirin |
| TicagrelorAlso: Brillinta | Drug | Ticagrelor |
Primary outcome
Saphenous Vein Graft Occlusion
Time frame: 1 year 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.
1 secondary outcome
Saphenous Vein Graft Stenosis
Time frame: 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29551675Kulik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Kulik, MD MPH principal investigator
Boca Raton Regional Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Ticagrelor in people with Saphenous Vein Graft Disease, run by Boca Raton Regional Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saphenous Vein Graft Occlusion (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.