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A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting (ATCCC)

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ClinicalTrials.gov Identifier: NCT02330640
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Zhe zheng, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.

Condition or disease Intervention/treatment Phase
Antiplatelet Therapy of Coronary Artery Bypass Drug: ticagrelor Drug: clopidogrel Drug: asprin Phase 4

Detailed Description:
Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post CABG has not been recommended by guideline, present studies indicated the patients could benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center prospective randomized controlled study
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ticagrelor
90mg Bid for 30days after first dose
Drug: ticagrelor
After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.

Active Comparator: clopidogrel
75mg Qd for 30days first dose
Drug: clopidogrel
After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.

asprin
100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG
Drug: asprin
All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study




Primary Outcome Measures :
  1. IPA at 2hours [ Time Frame: 2 hours after the first dose of study drug ]
    the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 2 hour in CABG patients after the first dose of study drug


Secondary Outcome Measures :
  1. the inhibition of platelet function (IPA%) measured by LTA at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug [ Time Frame: 0h, 8h, 24h, 3day, and 30day after the first dose of study drug ]
    the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug

  2. the platelet reactivity index at 0h, 2h, 8h, 24h,3day, and 30days [ Time Frame: 0h, 2h, 8h, 24h,3day, and 30day after the first dose of study drug ]
    the platelet reactivity index measured by corrected mean fluorescence intensities (MFIc) at 0h, 2h, 8h, 24h,3day, and 30day after the first dose of study drug in CABG patients.


Other Outcome Measures:
  1. The Number of Bleeding events according to BARC definition. [ Time Frame: 30 days after the operation ]
    All the bleeding events will be recorded with BARC definition type1-type5. Considering the specificity of operation, the BARC type1 or type2 bleeding events will not be recorded in the early period of post-operation (7days).

  2. The number of MACE events including all-cause mortality, myocardial infarction, urgent re-operation for heart, cerebral infarction, cerebral hemorrhage. [ Time Frame: 30 days after the operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and/or male and ≥ 18 and <80 years of age
  • Isolated CABG for the first time
  • either on- or off- pump

Exclusion Criteria:

  • Combined valvular surgery.
  • A second surgery.
  • Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).
  • Serum creatinine>130μmol/L.
  • Oral clopidogrel therapy stops less than 5 days before the surgery.
  • Oral anti-coagulation therapy (warfarin) that cannot be withheld.
  • History of gastrointestinal or vaginal bleeding, Active pathological bleeding (e.g. active gastroduodenal ulcer or cerebral haemorrhage), history of postoperative gastrointestinal bleeding.
  • Uric acid nephropathy, history of postoperative gastrointestinal bleeding.
  • History of cerebral haemorrhage.
  • Any other condition that may influence platelet count and function.
  • Postoperative chest drainage > 200 ml/hr for two hours and more, re-operation for bleeding with persistent cardiac tamponade.
  • Treated with IABP or ECMO after operation.
  • Any other condition that may put the patient at risk (e.g., recurrent ventricular arrhythmias, peri-operative myocardial infarction, cancer).
  • Contraindication to aspirin, clopidogrel and ticagrelor or other reason that study drug should not be administered (e.g., hypersensitivity, moderate or severe liver disease).
  • Previous enrollment in other investigational drug or device study within 30 days.

Being or planning to pregnant.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330640


Locations
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China, Beijing
FuWaiHospital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital

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Responsible Party: Zhe zheng, Cardiovascular Surgeon Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT02330640    
Other Study ID Numbers: Zzheng
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Zhe zheng, Chinese Academy of Medical Sciences, Fuwai Hospital:
CABG
antiplatelet therapy
ticagrelor
Additional relevant MeSH terms:
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Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs