AzTrials
AzTrials

Coronary DiseasePhase 4NCT02513004

Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Coronary Disease, run by Yongjian Wu at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This study is designed to test the hypothesis that the onset of the antiplatelet effect 90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of clopidogrel evaluated by P2Y12 reaction units measured by Verify NowTM P2Y12 assay at 1 hour in patients undergoing one-stop Hybrid coronary… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Disease
What is being tested?
Ticagrelor and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Jun 2015to Apr 2017
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 18 to 80 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
  • A patient who is considered as ethnic Chinese
  • 80years >aged> 18years, male or female
  • Patient is willing to perform HCR with the following conditions: Multi-vessel coronary artery disease with unfavorable left anterior descending coronary artery (LAD) for percutaneous coronary intervetion (PCI) (i.e., chronic total occlusion, excessive tortuosity, severely diffuse lesion), unprotected left main coronary artery disease, and non-LAD lesions were technically feasible for PCI with a drug-eluting stent (DES) .Limitations to traditional coronary artery bypass graft (CABG), such as pre-existing organ dysfunction, heavily calcified proximal aorta, or lack of suitable graft conduits

Who cannot join

  • Involvement in the planning and/or conduct of the study
  • Previous enrolment or randomization in the present study
  • Participation in another clinical study with an investigational product during the last 30 days
  • Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
  • With coagulation disorder
  • With uric acid nephropathy
Show all 30Show fewer
  • History of intolerance or allergy to acetylsalicylic acid (ASA) or clopidogrel or ticagrelor
  • Patient has a coronary artery bypass graft (CABG) history.
  • left subclavian artery and LIMA stenosis
  • buried intramyocardial LAD
  • need for a concomitant operation (e.g., valve repair or replacement)
  • overt congestive heart failure
  • Unsuccessful LIMA-LAD graft
  • hemodynamic instability
  • other conditions rendering PCI unsuitable (e.g., fresh thrombus, coronary vessel diameter <1.5 mm)
  • Platelet count less than 100*10^9/L
  • Haemoglobin (Hb) level less than 110g/L
  • White blood cell count less than 4*10^12/L
  • Recent (within 30 days of dosing) blood donation
  • Fibrinolytic therapy in the 24 hours prior to randomisation, or planned fibrinolytic treatment following randomisation (eg, for ST-segment elevation myocardial infarction or pulmonary embolism)
  • P2Y12 receptor inhibitor therapy in 7 days before HCR surgery.
  • Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
  • Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree atrioventricular block, third degree atrioventricular block or previous documented syncope suspected to be due to bradycardia).
  • Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers within 14 days of study treatment or cannot be stopped for the course of the study.
  • Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice.
  • Substrates with narrow therapeutic index: cyclosporine, quinidine. Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine. The sponsor should be consulted for enrolment with any concomitant medicines which are suspected of undergoing strong drug-drug interaction
  • Any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock or active cancer)
  • Moderate or severe renal disease;
  • Moderate or severe chronic lung disease or asthma;
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

Yongjian Wu, professor contact

008613701387189

nankedoudou@126.com

Qian Zhang contact

008618810803269

fuwaihospital@hotmail.com

China1 site, 1 recruiting

  • Fuwai hospital

    Beijing, Beijing Municipality

    Yongjian Wu, Doctor, 008618613819658, nankedoudou@126.com

    Recruiting

Other trials in China

About this study

Official title: Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel in Patients Undergoing "One-stop" Hybrid Coronary Revascularization

This study is designed to test the hypothesis that the onset of the antiplatelet effect 90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of clopidogrel evaluated by P2Y12 reaction units measured by Verify NowTM P2Y12 assay at 1 hour in patients undergoing one-stop Hybrid coronary revascularization(HCR).

Read the detailed description

This is a single-center, randomized, active-controlled, open-label, prospective study, and the study is designed to test the hypothesis that the onset of the antiplatelet effect 90mg-first-dose of ticagrelor will be more rapid and greater than 300mg-loading-dose of clopidogrel evaluated by P2Y12 reaction units (PRU) measured by Verify NowTM P2Y12 assay at 1 hour in patients undergoing one-stop HCR. The first dose of study drug (ticagrelor 90mg or clopidogrel 300 mg) will be administered as powder via a nasogastric tube after confirmation of left internal mammal artery to left anterior descending coronary antery (LIMA-LAD) graft patency during the HCR procedure. Approximately 60 patients will enrol for the study. Patients will be randomized equally (ratio 1:1) to the two treatment arms of this study. The anticipated duration of the study is approximately 15 months, including an anticipated enrolment period of 12 months and follow-up period of 3months.

Being tested
Ticagrelor, Clopidogrel
Medical subject headings
Coronary Disease

What participants receive

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

  • TicagrelorDrug

    Also called BRILINTA

    Patients will receive first dose of 90mg ticagrelor tablets (powdered) taken via nasogastric tube after LIMA-LAD bypass establishing, the close of thorax and before PCI procedure, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor will be given to patients after the 24 hour blood sample has been obtained and 24 hours after the first dose. Thereafter, the patients will take 90mg of ticagrelor orally bid, at approximately 12-hourly intervals. The total study period is 3 months.

  • ClopidogrelDrug

    Also called PLAVIX

    Patients will receive a loading dose of 300mg clopidogrel tablets (four 75mg capsules powdered) taken via nasogastric tube after LIMA-LAD bypass establishing, the close of thorax and before PCI procedure. The second dose of clopidogrel will be given to patients after the 24 hour blood sample has been obtained and 24 hours after the first dose. Thereafter, the patients will take 75mg of clopidogrel capsules orally od. The total study period is 3 months.

Study groups in NCT02513004
Study groupRoleWhat they receive
TicagrelorExperimentalPatients will receive first dose of 90mg ticagrelor tablets (powdered) taken via nasogastric tube after LIMA-LAD bypass establishing, the close of thorax and before PCI procedure, followed by 90mg of ticagrelor 12 hours after the first dose.Thereafter, the patients will take 90mg of ticagrelor orally bid, at approximately 12-hourly intervals. The total study period is 3 months.
Receives: Drug: Ticagrelor
ClopidogrelActive comparatorPatients will receive a loading dose of 300mg clopidogrel tablets (four 75mg capsules powdered) taken via nasogastric tube after LIMA-LAD bypass establishing, the close of thorax and before PCI procedure. Thereafter, the patients will take 75mg of clopidogrel capsules orally od. The total study period is 3 months.
Receives: Drug: Clopidogrel

What is being measured

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

  1. 1hourPRU

    PRU measured by Verify NowTM P2Y12 assay at 1 hour after first dose of study drug administered as powder via a nasogastric tube after confirmation of LIMA-LAD graft patency during the HCR procedure in HCR patients.

    Measured: 1hour

Secondary outcomes (1)

  1. 30min,1h,2h,6h,12h,24h PRU

    PRU measured by Verify NowTM P2Y12 assay at 30min,1h, 2h，6h,12h,24h after first dose of study drugs.

    Measured: 30min,1h,2h,6h,12h,24h after first dose

Timeline

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

  1. First posted31 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionApr 2017 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02513004
Sponsor's protocol ID
2014-ZX46
Status last verified
Feb 2017
First submitted
14 Jun 2015
Last updated
9 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Shen L, Hu S, Wang H, Xiong H, Zheng Z, Li L, Xu B, Yan H, Gao R. One-stop hybrid coronary revascularization versus coronary artery bypass grafting and percutaneous coronary intervention for the treatment of multivessel coronary artery disease: 3-year follow-up results from a single institution. J Am Coll Cardiol. 2013 Jun 25;61(25):2525-33. doi: 10.1016/j.jacc.2013.04.007. Epub 2013 Apr 23.

    PubMed 23623906

  • Hu S, Li Q, Gao P, Xiong H, Zheng Z, Li L, Xu B, Gao R. Simultaneous hybrid revascularization versus off-pump coronary artery bypass for multivessel coronary artery disease. Ann Thorac Surg. 2011 Feb;91(2):432-8. doi: 10.1016/j.athoracsur.2010.10.020.

    PubMed 21256284

  • Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

    PubMed 19717846

  • Eikelboom JW, Hirsh J, Spencer FA, Baglin TP, Weitz JI. Antiplatelet drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e89S-e119S. doi: 10.1378/chest.11-2293.

    PubMed 22315278

  • Kuliczkowski W, Witkowski A, Polonski L, Watala C, Filipiak K, Budaj A, Golanski J, Sitkiewicz D, Pregowski J, Gorski J, Zembala M, Opolski G, Huber K, Arnesen H, Kristensen SD, De Caterina R. Interindividual variability in the response to oral antiplatelet drugs: a position paper of the Working Group on antiplatelet drugs resistance appointed by the Section of Cardiovascular Interventions of the Polish Cardiac Society, endorsed by the Working Group on Thrombosis of the European Society of Cardiology. Eur Heart J. 2009 Feb;30(4):426-35. doi: 10.1093/eurheartj/ehn562. Epub 2009 Jan 27.

    PubMed 19174428

  • Gurbel PA, Bliden KP, Zaman KA, Yoho JA, Hayes KM, Tantry US. Clopidogrel loading with eptifibatide to arrest the reactivity of platelets: results of the Clopidogrel Loading With Eptifibatide to Arrest the Reactivity of Platelets (CLEAR PLATELETS) study. Circulation. 2005 Mar 8;111(9):1153-9. doi: 10.1161/01.CIR.0000157138.02645.11. Epub 2005 Feb 28.

    PubMed 15738352

  • Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.

    PubMed 19923168

  • Li Y, Zheng Z, Xu B, Zhang S, Li W, Gao R, Hu S. Comparison of drug-eluting stents and coronary artery bypass surgery for the treatment of multivessel coronary disease: three-year follow-up results from a single institution. Circulation. 2009 Apr 21;119(15):2040-50. doi: 10.1161/CIRCULATIONAHA.108.819730. Epub 2009 Apr 6.

    PubMed 19349321

  • Vandvik PO, Lincoff AM, Gore JM, Gutterman DD, Sonnenberg FA, Alonso-Coello P, Akl EA, Lansberg MG, Guyatt GH, Spencer FA. Primary and secondary prevention of cardiovascular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e637S-e668S. doi: 10.1378/chest.11-2306.

    PubMed 22315274

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Coronary Disease, run by Yongjian Wu at 1 site in China.

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 4 inclusion and 30 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 9 Feb 2017. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongjian Wu, professor (008613701387189, nankedoudou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1hourPRU (time frame: 1hour). 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 NCT02513004, which also lists 9 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 9 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in