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Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02201771
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : July 1, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Qiang Zhao,MD, Ruijin Hospital

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 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

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aspirin
aspirin 100mg tablet by mouth daily for 12 months
Drug: Aspirin
Experimental: Ticagrelor plus Aspirin
ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months
Drug: Aspirin
Drug: Ticagrelor
Experimental: Ticagrelor
ticagrelor 90mg tablet by mouth twice daily for 12 months
Drug: Ticagrelor



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. 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".

  2. 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

  3. 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

  4. 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)

  5. 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).


Other Outcome Measures:
  1. The Rate of Gastroduodenal Injury Assessed by Esophagogastroduodenoscopy (EGD) [ Time Frame: at 12 months ]
    Not all but the patients recruited in Ruijin Hospital



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:

  • 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 Criteria:

  • 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)

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): NCT02201771


Locations
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China, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan, China
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nan Jing First Hospital
Nanjing, Jiangsu, China
China, Shanghai
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
Sponsors and Collaborators
Ruijin Hospital
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Qiang Zhao,MD, Ruijin Hospital:
Study Protocol  [PDF] March 7, 2017
Statistical Analysis Plan  [PDF] August 28, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qiang Zhao,MD, Vice President of Ruijin Hospital, Professor and director, Department of Cardiac Surgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02201771    
Other Study ID Numbers: ISSBRIL0211
First Posted: July 28, 2014    Key Record Dates
Results First Posted: July 1, 2019
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Qiang Zhao,MD, Ruijin Hospital:
CABG
Antiplatelet
Ticagrelor
Additional relevant MeSH terms:
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Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents