Status:
COMPLETED
Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery
Lead Sponsor:
Ruijin Hospital
Conditions:
Coronary Artery Bypass
Antiplatelet Agents
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The study population will include all patients undergoing elective CABG. Consent and randomization will occur before surgery. Total 500 patients undergoing elective CABG will be randomly assigned into...
Detailed Description
The study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patenc...
Eligibility Criteria
Inclusion
- Patients able to provide written informed consent
- Provision of informed consent prior to any study specific procedures
- Female and male patients aged 18-80 years
- Indication for CABG surgery
Exclusion
- Cardiogenic shock, haemodynamic instability
- Need for urgent revascularization within 5 days from presentation
- Single vessel disease
- Two vessel disease with normal left ventricular function (\> 50%)
- Need for concomitant other cardiac surgery (e.g. valve replacement)
- Need for dual antiplatelet treatment for the patients undergoing CABG after acute coronary syndrome(ACS)
- Contraindication for aspirin and ticagrelor use(e.g. known allergy)
- History of bleeding diathesis within 3 months prior presentation
- History of significant GI bleed within 1 year prior presentation
- History of peptic ulcer without GI bleeding in past 3 years
- History of intracranial hemorrhage
- History of moderate to severe liver impairment
- Patient requires dialysis
- Patient with an increased risk of bradycardic events (as patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree arteriolar-venular block or bradycardic-related syncope)
- Need vitamin K antagonist therapy after bypass surgery eg. persistent atrial fibrillation, mechanical valves
- Known, clinically important thrombocytopenia(i.e. \< 100\*109/L)
- Known, clinically important anaemia (i.e. \<100g/L)
- Participation in another investigational drug or device study in the last 30 days
- Pregnancy or lactation(for premenopausal women 2 methods of reliable contraception, one of which must barrier method, are required)
- Concomitant oral or intravenous therapy with strong cytochrome P450 3A4(CYP3A4) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers which cannot be stopped for the course of the study (strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice. Substrates with narrow therapeutic index: cyclosporine, quinidine. Strong inducers: rifampin, phenytoin, carbamazepine. )
- Any other condition such as active cancer
- Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow up
- Indication for major surgery(e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02201771
Start Date
July 1 2014
End Date
January 1 2017
Last Update
August 13 2019
Active Locations (6)
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1
Henan Provincial People's Hospital
Zhengzhou, Henan, China
2
Jiangsu Province Hospital
Nanjing, Jiangsu, China
3
Nan Jing First Hospital
Nanjing, Jiangsu, China
4
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025