NCT02513004

Brief 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 revascularization(HCR).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

June 14, 2015

Last Update Submit

February 8, 2017

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (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.

    1hour

Secondary Outcomes (1)

  • 30min,1h,2h,6h,12h,24h PRU

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

Other Outcomes (1)

  • safety assessed by the bleeding risk of ticagrelor compared with clopidogrel in the peri-operative and in-hospital period and 3 months follow-up.

    3 monthes

Study Arms (2)

Ticagrelor

EXPERIMENTAL

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.Thereafter, the patients will take 90mg of ticagrelor orally bid, at approximately 12-hourly intervals. The total study period is 3 months.

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

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. Thereafter, the patients will take 75mg of clopidogrel capsules orally od. The total study period is 3 months.

Drug: Clopidogrel

Interventions

TicagrelorDRUG

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.

Also known as: BRILINTA
Ticagrelor
ClopidogrelDRUG

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.

Also known as: PLAVIX
Clopidogrel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • A patient who is considered as ethnic Chinese
  • years \>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

You may not qualify if:

  • 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
  • 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)
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 23623906RESULT

  • 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.

    PMID: 21256284RESULT

  • 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.

    PMID: 19717846RESULT

  • 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.

    PMID: 22315278RESULT

  • 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.

    PMID: 19174428RESULT

  • 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.

    PMID: 15738352RESULT

  • 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.

    PMID: 19923168RESULT

  • 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.

    PMID: 19349321RESULT

  • 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.

    PMID: 22315274RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yongjian Wu, Professor

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongjian Wu, professor

CONTACT

008613701387189nankedoudou@126.com

Qian Zhang

CONTACT

008618810803269fuwaihospital@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2015

First Posted

July 31, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

CN(1)