Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB)
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|ClinicalTrials.gov Identifier: NCT02201771|
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : July 1, 2019
Last Update Posted : August 13, 2019
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 three groups with 1:1:1 ratio(167 patients per group) in this open-label study. All the enrolled patients will stop oral antiplatelet drugs according to local protocol before the surgery. Within the first 24 hours after surgery, study medication should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients will undergo a multislice computed tomography angiography to assess vein graft patency.
This 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 patency.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Antiplatelet Agents||Drug: Aspirin Drug: Ticagrelor||Phase 4|
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 patency. The primary comparison includes two separate parts. One is to demonstrate T+A better than A and the other is T better than A.
One year rate of vein graft patency in the aspirin group is estimated as 80%. The assumed rate of ticagrelor plus aspirin is 90%. With a two-sided alpha level 0.05 and 80% power, 199 grafts to each group are required. On the other hand, if we assume the rate of ticagrelor monotherapy has the 1-year vein graft patency rate of 87%, under the same two-sided 0.05 alpha 441 grafts in each arm will offer 80% power to show the superiority of ticagrelor along for the primary efficacy end point.
Combined the above two assumptions, if the allocation rate is 1:1:1, this study needs to recruit 1,323 grafts in total (441 in each) to achieve the pre-specified power for both the two comparisons (T+A vs. A and T vs. A).
The principle investigator assumes that the average number of the vien grafts in one patient is 2.7-3.0. With this assumption, 500 patients are to be recruited, which will provide us a total of 1350 - 1500 grafts.
According to the above, this study will be a confirmatory clinical trial to the primary endpoint.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Active Comparator: Aspirin
aspirin 100mg tablet by mouth daily for 12 months
Experimental: Ticagrelor plus Aspirin
ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months
ticagrelor 90mg tablet by mouth twice daily for 12 months
- The Patency of Saphenous Vein Grafts [ Time Frame: up to 12 months ]assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis <50%) is defined as "patency".
- The Patency of Saphenous Vein Grafts [ Time Frame: up to 7 days ]assessed by MSCTA or CAG. FitzGibbon grade A (stenosis <50%) is defined as "patency".
- The Rate of Post-operative Atrial Fibrillation After CABG. [ Time Frame: up to 7 days ]Number of Participants with Post-operative Atrial Fibrillation after CABG
- The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification [ Time Frame: up to 12 months ]Number of Participants Free of Angina per CCS Classification
- The Number of Major Adverse Cardiovascular Event (MACE) [ Time Frame: up to 12 months ]MACE, composite of CV death, myocardial infarction or stroke (ischaemic or unknown etiology)
- Number of the Major Bleeding Events [ Time Frame: up to 12 months ]According to modified TIMI criteria, the "Major Bleeding Events" is defined as the combination of CABG-related bleeding and non-CABG-related major bleeding(Intracranial bleeding, Clinically overt signs of hemorrhage with hemoglobin drop ≥5 g/dL and Fatal bleeding).
- The Rate of Gastroduodenal Injury Assessed by Esophagogastroduodenoscopy (EGD) [ Time Frame: at 12 months ]Not all but the patients recruited in Ruijin Hospital
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): NCT02201771
|Henan Provincial People's Hospital|
|Zhengzhou, Henan, China|
|Jiangsu Province Hospital|
|Nanjing, Jiangsu, China|
|Nan Jing First Hospital|
|Nanjing, Jiangsu, China|
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine|
|Shanghai, Shanghai, China, 200025|
|Xinhua Hospital, Shanghai Jiaotong University School of Medicine|
|Shanghai, Shanghai, China, 200092|
|Changhai Hospital of Shanghai|
|Shanghai, Shanghai, China, 200433|
|Principal Investigator:||Qiang Zhao, MD.PhD||Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China|
|Study Director:||Yunpeng Zhu, MD.||Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China|