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)

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

China, Beijing

FuWaiHospital

Beijing, Beijing, China, 100000

Sponsors and Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

More Information

• 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
• 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:

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