Coronary Artery DiseasePhase 4TAP-CABGNCT01373411
Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery
A Phase 4 study testing ticagrelor in people with Coronary Artery Disease, run by Cardiology Research UBC at 1 site in Canada.
Trial summary
Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG
- Females of child-bearing age must have a negative pregnancy test at enrollment
Who cannot join
- Patients undergoing combined valve or aortic surgeries
- Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
- Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
- Patients with active bleeding or history of bleeding diathesis
- Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
- Patients with severe liver disease (e.g. ascites or signs of coagulopathy)
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- Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker
- Patients with end-stage renal failure requiring dialysis
- For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)
Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.
Read the detailed description
Patients will be screened for eligibility pre-CABG, and informed consent signed before randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine practice. Study medication will be started within 48 hours after CABG if there are no contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year post-CABG. Other cardiac medications will be at the discretion of the treating physicians as per standard practice.
Patients will be followed daily during their hospital stay. Outpatient visits will be scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.
CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter if there are disagreements. If no consensus could be reached among the 3 interpreters, the graft will be deemed not analyzable, or be subject to invasive coronary angiography for definitive assessment if clinically indicated.
The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat revascularization within 1 year following CABG. Secondary endpoints include the individual endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- ticagrelor, Placebo
- Keywords
- CABG, Ticagrelor, Coronary Artery Bypass Surgery
- 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.
ticagrelorDrug
Also called Brilinta
ticagrelor 90 mg BID for 90 days
PlaceboDrug
Placebo 1 pill BID for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo twice daily. Study drug will be started within 48 hours of CABG. Receives: Drug: Placebo |
| ticagrelor 90 mg | Active comparator | Taken twice daily. Study drug will be started within 48 hours of CABG. Receives: Drug: ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, MI, stroke, or repeat revascularization
Measured: within one year following CABG
Secondary outcomes (1)
Improving graft patency
The secondary study objective is to evaluate if the combination of ticagrelor and aspirin administered after CABG will improve graft patency at 3 months, compared with aspirin alone. This will be monitored and assessing in the CT angiography substudy.
Measured: 3 months post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Dr. Jacqueline Saw, Cardiology Research UBC
- Investigators
- Jackie Saw, BSc, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373411
- Sponsor's protocol ID
- H10-01452
- Acronym
- TAP-CABG
- Status last verified
- Mar 2013
- First submitted
- 13 Jun 2011
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saw J, Wong GC, Mayo J, Bernstein V, Mancini GB, Ye J, Skarsgard P, Starovoytov A, Cairns J. Ticagrelor and aspirin for the prevention of cardiovascular events after coronary artery bypass graft surgery. Heart. 2016 May 15;102(10):763-9. doi: 10.1136/heartjnl-2015-308691. Epub 2016 Feb 18.
PubMed 26891756
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)
- ClinicalTrials.gov ID
- NCT01373411
- Acronym / sponsor ID
- TAP-CABG / H10-01452
- Conditions
- Coronary Artery Disease
- Keywords
- CABG, Ticagrelor, Coronary Artery Bypass Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.
Detailed description
Patients will be screened for eligibility pre-CABG, and informed consent signed before randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine practice. Study medication will be started within 48 hours after CABG if there are no contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year post-CABG. Other cardiac medications will be at the discretion of the treating physicians as per standard practice.
Patients will be followed daily during their hospital stay. Outpatient visits will be scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.
CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter if there are disagreements. If no consensus could be reached among the 3 interpreters, the graft will be deemed not analyzable, or be subject to invasive coronary angiography for definitive assessment if clinically indicated.
The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat revascularization within 1 year following CABG. Secondary endpoints include the individual endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily. Study drug will be started within 48 hours of CABG. |
| ticagrelor 90 mg | Active comparator | Drug: ticagrelorTaken twice daily. Study drug will be started within 48 hours of CABG. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG
- Females of child-bearing age must have a negative pregnancy test at enrollment
Key exclusion criteria (9 listed)
- Patients undergoing combined valve or aortic surgeries
- Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
- Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
- Patients with active bleeding or history of bleeding diathesis
- Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
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 |
|---|---|---|
| ticagrelorAlso: Brilintaticagrelor 90 mg BID for 90 days | Drug | ticagrelor 90 mg |
| PlaceboPlacebo 1 pill BID for 90 days | Drug | Placebo |
Primary outcome
Composite of all-cause mortality, MI, stroke, or repeat revascularization
Time frame: within one year following CABG
1 secondary outcome
Improving graft patency
Time frame: 3 months post-CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Derived from this study: PubMed 26891756Saw J, Wong GC, Mayo J, Bernstein V, Mancini GB, Ye J, Skarsgard P, Starovoytov A, Cairns J. Ticagrelor and aspirin for the prevention of cardiovascular events after coronary artery bypass graft surgery. Heart. 2016 May 15;102(10):763-9. doi: 10.1136/heartjnl-2015-308691. Epub 2016 Feb 18.
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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.
Jackie Saw, BSc, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor in people with Coronary Artery Disease, run by Cardiology Research UBC at 1 site in Canada.
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 2 inclusion and 9 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of all-cause mortality, MI, stroke, or repeat revascularization (time frame: within one year following CABG). 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 NCT01373411, 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 26 Mar 2015.