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DACAB Trial: Follow-up Extension (DACAB-FE)

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: NCT03987373
Recruitment Status : Enrolling by invitation
First Posted : June 17, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Qiang Zhao,MD, Ruijin Hospital

Brief Summary:

This study will include the subjects who enrolled in DACAB trial (NCT02201771) to observe clinical outcomes 5 years after coronary artery bypass grafting(CABG).

The primary objective is to observe the occurrence of major adverse clinical events (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization) among 3 groups in DACAB trial within 5 years after CABG.

The secondary objectives are to observe the occurrence of major adverse cardiovascular events (a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke); all-cause death; cardiovascular death; non-fatal myocardial infarction; non-fatal stroke; coronary revascularization; grafts patency rate among 3 groups in previous DACAB trial within 5 years after CABG.


Condition or disease Intervention/treatment
Coronary Artery Bypass Grafting Antiplatelet Therapy Other: non-interventional

Detailed Description:

This study is designed to observe clinical outcomes 5 years after CABG in subjects enrolled in DACAB trial.

After completing 12-month treatment from DACAB trial, investigators would not make any interventions or impact on subjects' therapeutic strategy. Aspirin monotherapy would be given to subjects according to the current guidelines. However, other antiplatelet regimens might be given for subjects by their attending physician based on the subject's individual condition. Subjects would spontaneously undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG), coronary computed tomographic angiography(CCTA) or coronary angiography(CAG) and clinical follow-up according to clinical need and their individual condition. At 5-year (± 3 month) after CABG, a face-to-face visit is scheduled to be performed to collect the occurrence of clinical events, including types and time of events.

So this study is a non-interventional, observational study.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery: Follow-up Extension
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: non-interventional
    This study is a non-interventional, observational study. After completing 12-month treatment from DACAB trial, investigators would not make any interventions or impact on subjects' therapeutic strategy.


Primary Outcome Measures :
  1. The time to the first major adverse clinical events [ Time Frame: within 5 year after CABG ]
    The time to the first occurrence of any major adverse clinical events, defined as a composite of death, non-fatal myocardial infarction, non-fatal stroke or coronary revascularization


Secondary Outcome Measures :
  1. The time to the first major adverse cardiovascular events (MACE) [ Time Frame: within 5 year after CABG ]
    The time to first occurrence of any MACE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke within 5 years after CABG.

  2. The time to the first occurrence of all-cause death. [ Time Frame: within 5 year after CABG ]
  3. The time to the first cardiovascular death [ Time Frame: within 5 year after CABG ]
  4. The time to the first non-fatal myocardial infarction [ Time Frame: within 5 year after CABG ]
  5. The time to the first non-fatal stroke [ Time Frame: within 5 year after CABG ]
  6. The time to the first repeated coronary revascularization [ Time Frame: within 5 year after CABG ]
  7. Grafts patency rate (Fitzgibbon Grade A). [ Time Frame: at 5 years after CABG ]


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
Sampling Method:   Non-Probability Sample
Study Population
This study will include the subjects who enrolled in DACAB trial
Criteria

Inclusion Criteria:

  • This study will include the subjects who enrolled in DACAB trial

Exclusion Criteria:

  • This study will include the subjects who enrolled in DACAB trial

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): NCT03987373


Locations
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China, Henan
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China, 450003
China, Jiangsu
Nan Jing First Hospital
Nanjing, Jiangsu, China, 210029
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 21002
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 Ruijin Hospital
Study Director: Yunpeng Zhu, MD Ruijin Hospital
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Responsible Party: Qiang Zhao,MD, Professor and director, Department of Cardiac Surgery,Vice President of Ruijin Hospital, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03987373    
Other Study ID Numbers: ESR-18-13658
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qiang Zhao,MD, Ruijin Hospital:
CABG
Antiplatelet
MACE
grafts patency