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Coronary Artery DiseasePhase 3POPular CABGNCT02352402

The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery

A Phase 3 study testing Ticagrelor in people with Coronary Artery Disease and Stable Angina, run by J.M. ten Berg at 6 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous vein graft occlusion as assessed with coronary computed tomography angiography at 1 year after coronary artery bypass grafting surgery. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Ticagrelor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
487 participants
Where
6 sitesNetherlands
Study dates
Mar 2015to Aug 2020
Phase
Phase 3
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • More than 21 years of age
  • Planned coronary artery bypass grafting (CABG) with the use of 1 or more saphenous vein grafts, CABG being an isolated procedure or part of a combined aortic valce replacement surgery with bioprothesis.

Who cannot join

  • Unable to give informed consent or a life expectancy of less than 1 year
  • Concomitant valve, aorta or rhythm surgery during the same session, (excluding aortic bioprothesis)
  • Inability to undergo coronary computed tomography angiography, in the investigator's opinion, for instance due to severe claustrophobia or contrast allergy
  • Use of oral anticoagulants (acenocoumarol, phenprocoumon, dabigatran, rivaroxaban, etc) and a contraindication for discontinuation of this medication or the expectation that the patient will have an indication for the use of these drugs after surgery
  • Placement of a drug-eluting stent in a coronary or cerebral artery within 6 months of CABG or placement of a bare-metal stent in a coronary or cerebral artery within 1 month of CABG
  • Use of antiplatelet drugs other than aspirin (clopidogrel, prasugrel, ticagrelor, dipyridamol, etc.) and a contraindication for discontinuation of this medication after CABG, according to the treating physician or the investigator
Show all 15Show fewer
  • Women who are known to be pregnant, who have given birth within the past 90 days or who are breastfeeding
  • Pre-menopausal women without adequate contraception
  • Severe renal function impairment requiring dialysis
  • Moderate or severe hepatic impairment
  • Active malignancy with increase in bleeding risk, in the investigator's opinion
  • Use of strong inhibitors of CYP3A4 (e.g. ketaconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
  • Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion
  • Contraindication for the use of ticagrelor or aspirin (i.e. history of intracranial bleeding, high bleeding risk, previous allergic reaction), in the investigator's opinion
  • Previous inclusion in this study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Medisch Spectrum Twente

    Enschede

  • Universitair Medisch Centrum Groningen

    Groningen

  • St Antonius Hospital

    Nieuwegein, Utrecht, 3435CM

  • Radboud UMC

    Nijmegen

  • Erasmus Erasmus UMC

    Rotterdam

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery (The POPular CABG Study)

In the POPular CABG study we investigate if the addition of ticagrelor, a drug that inhibits blood platelets from clotting, to treatment with aspirin will reduce the rate of saphenous vein graft occlusion as assessed with coronary computed tomography angiography at 1 year after coronary artery bypass grafting surgery.

Read the detailed description

Rationale: Acetylsalicylic acid (ASA) is used to prevent the occlusion of grafts placed during coronary artery bypass grafting surgery (CABG) and to reduce the incidence of atherothrombotic events during follow-up. Graft occlusion occurs predominantly in saphenous vein grafts (SVGs) and can result in symptoms of chest pain, myocardial infarction (MI) and even death. The anti-thrombotic effect of ASA is a result of the inhibition of the generation of thromboxane A2 (TXA2) in blood platelets. Despite ASA therapy, 6.8% to 26% of SVGs occlude in the first year after CABG, mainly due to thrombus formation. This might be due to the fact that ASA is not equally effective in all patients, indicated by a substantial amount of patients that still generate TXA2 and show activated platelets, despite adequate ASA use. We hypothesize that more potent platelet inhibition by the addition of ticagrelor to standard ASA therapy could decrease the rate of SVG occlusion.

Main objective: To investigate whether a combination of ticagrelor 90mg twice daily and ASA 80mg once daily is superior to ASA 80mg once daily alone in the prevention of SVG occlusion in patients who underwent CABG with use of one or more SVGs, as assessed with coronary computed tomography angiography (CCTA) at 1 year after randomization.

Study design: Randomized, double-blind, placebo-controlled, multicenter trial. Number of patients: Approximately 500 patients will be randomized.

Study population: Patients undergoing CABG with one or more SVGs, CABG being an isolated procedure or part of combined surgery.

Informed consent procedure, screening and sample size: We will screen patients and obtain informed consent before CABG. After CABG patients who gave informed consent are screened again to check if the patient fulfills the inclusion criteria and does not have any exclusion criteria. A total of 500 patients will receive randomized study medication after CABG.

Intervention: Patients will be randomly assigned to treatment with 90mg of ticagrelor or a matching placebo twice daily in addition to standard treatment with ASA for the duration of 1 year. Patients will be prescribed 80mg of ASA once daily according to routine clinical practice. Graft patency will be assessed with CCTA 1 year after randomization. If the patient consents to participate in the substudies, platelet function tests will be performed before surgery and 3 days and 1 year after randomization. Thirty day and one-year follow-up of clinical events will be obtained for all patients by screening the (electronic) patient file, telephonic interviews, study site visits and possibly with questionnaires.

Being tested
Ticagrelor, Placebo
Keywords
CABG, Ticagrelor, Graft, Patency
Medical subject headings
Coronary Artery Disease, Angina, Stable, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brilique, Brillinta

  • PlaceboDrug

Study groups in NCT02352402
Study groupRoleWhat they receive
TicagrelorExperimentalTicagrelor 90mg twice daily for 1 year on top of ASA
Receives: Drug: Ticagrelor
PlaceboPlacebo comparatorPlacebo matching ticagrelor 90mg twice daily on top of ASA
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Saphenous vein graft occlusion

    As assessed with coronary computed tomography angiography or clinically indicated coronary angiography

    Measured: 1 year after coronary artery bypass grafting

Secondary outcomes (15)

  1. Saphenous vein graft failure

    Composite of saphenous vein graft occlusion as assessed with coronary computed tomography angiography or clinically indicated coronary angiography, saphenous vein graft revascularization, myocardial infarction in the myocardial territory supplied by a saphenous vein graft or sudden death

    Measured: 1 year after coronary artery bypass grafting

  2. Significant saphenous vein graft stenosis

    As assessed with coronary computed tomography angiography or clinically indicated coronary angiography

    Measured: 1 year after coronary artery bypass grafting

  3. BARC minor (type 1 or 2) and major (type 3, 4 or 5) bleeding

    Bleeding Academic Research Consortium bleeding criteria

    Measured: 30 days after coronary artery bypass grafting

  4. BARC minor (type 1 or 2) and major (type 3, 4 or 5) bleeding

    Bleeding Academic Research Consortium bleeding criteria

    Measured: 1 year after coronary artery bypass grafting

  5. TIMI minor and major bleeding

    Thrombolysis in Myocardial Infarction bleeding criteria

    Measured: 30 days after coronary artery bypass grafting

  6. TIMI minor and major bleeding

    Thrombolysis in Myocardial Infarction bleeding criteria

    Measured: 1 year after coronary artery bypass grafting

  7. High platelet reactivity

    As assessed with platelet function tests.

    Measured: Within 72h before coronary artery bypass grafting

  8. High platelet reactivity

    As assessed with platelet function tests.

    Measured: 3 days after coronary artery bypass grafting

  9. High platelet reactivity

    As assessed with platelet function tests.

    Measured: 1 year after coronary artery bypass grafting

  10. Level of GDF-15

    Growth differentiation factor 15 level

    Measured: Within 72h before coronary artery bypass grafting

  11. Level of GDF-15

    Growth differentiation factor 15 level

    Measured: 3 days after coronary artery bypass grafting

  12. Level of GDF-15

    Growth differentiation factor 15 level

    Measured: 1 year after coronary artery bypass grafting

  13. Arterial graft occlusion

    As assessed with coronary computed tomography angiography or clinically indicated coronary angiography

    Measured: 1 year after coronary artery bypass grafting

  14. All graft occlusion

    As assessed with coronary computed tomography angiography or clinically indicated coronary angiography

    Measured: 1 year after coronary artery bypass grafting

  15. Significant arterial graft stenosis

    As assessed with coronary computed tomography angiography or clinically indicated coronary angiography

    Measured: 1 year after coronary artery bypass grafting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionAug 2020 (estimated)
  4. Study completionAug 2020 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
487 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352402
Sponsor's protocol ID
POPCABG
Other IDs
2014-002142-50, 2014
Acronym
POPular CABG
Status last verified
Apr 2020
First submitted
19 Sep 2014
Last updated
27 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Willemsen LM, Janssen PWA, Hackeng CM, Kelder JC, Tijssen JGP, van Straten AHM, Soliman-Hamad MA, Deneer VHM, Daeter EJ, Sonker U, Klein P, Ten Berg JM. A randomized, double-blind, placebo-controlled trial investigating the effect of ticagrelor on saphenous vein graft patency in patients undergoing coronary artery bypass grafting surgery-Rationale and design of the POPular CABG trial. Am Heart J. 2020 Feb;220:237-245. doi: 10.1016/j.ahj.2019.12.001. Epub 2019 Dec 13.

    PubMed 31884246

  • Willemsen LM, Janssen PWA, Peper J, Soliman-Hamad MA, van Straten AHM, Klein P, Hackeng CM, Sonker U, Bekker MWA, von Birgelen C, Brouwer MA, van der Harst P, Vlot EA, Deneer VHM, Chan Pin Yin DRPP, Gimbel ME, Beukema KF, Daeter EJ, Kelder JC, Tijssen JGP, Rensing BJWM, van Es HW, Swaans MJ, Ten Berg JM. Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial. Circulation. 2020 Nov 10;142(19):1799-1807. doi: 10.1161/CIRCULATIONAHA.120.050749. Epub 2020 Aug 31.

    PubMed 32862716

  • Feitosa MPM, Soffiatti CD, Linhares Filho JPP, Batista DV, Lobo Filho HG, Lima EG, Serrano Junior CV. Dual platelet antiaggregation therapy after myocardial revascularization surgery. Rev Assoc Med Bras (1992). 2019 Mar;65(3):316-318. doi: 10.1590/1806-9282.65.3.316. Epub 2019 Apr 11.

    PubMed 30994825

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor in people with Coronary Artery Disease and Stable Angina, run by J.M. ten Berg at 6 sites in Netherlands.

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 15 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: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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 coronary artery bypass grafting). 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 NCT02352402, which also lists 3 linked publications.

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 27 Apr 2020.

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