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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ticagrelor | Experimental | 90mg Bid for 30days after first dose |
|
| clopidogrel | Active Comparator | 75mg Qd for 30days first dose |
|
| asprin | Other | 100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| IPA at 2hours | the platelet inhibition (IPA %) measured by light-transmittance aggregometry at 2 hour in CABG patients after the first dose of study drug | 2 hours after the first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| the inhibition of platelet function (IPA%) measured by LTA at 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 | 0h, 8h, 24h, 3day, and 30day after the first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Bleeding events according to BARC definition. | 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). | 30 days after the operation |
Inclusion Criteria:
Exclusion Criteria:
Being or planning to pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FuWaiHospital | Beijing | Beijing Municipality | 100000 | China |
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Single center prospective randomized controlled study
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|
| clopidogrel | Drug | 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 | Drug | All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study |
|
| the platelet reactivity index at 0h, 2h, 8h, 24h,3day, and 30days |
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. |
| 0h, 2h, 8h, 24h,3day, and 30day after the first dose of study drug |
| The number of MACE events including all-cause mortality, myocardial infarction, urgent re-operation for heart, cerebral infarction, cerebral hemorrhage. |
| 30 days after the operation |
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| C010395 | acetylsalicylic acid lysinate |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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