DACAB Trial: Follow-up Extension

NCT03987373 | Completed

• 1 other identifier: ESR-18-13658
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 6

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 compare the occurrence of MACE-4 ( a composite of all-cause death, myocardial infarction, stroke, and coronary revascularization) among 3 randomized regimens (T+A, T alone, A alone) in previous DACAB trial within 5 years after CABG. The secondary objectives are to compare the occurrence of MACE-5( a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina); MACE-3 ( a composite of cardiovascular death, myocardial infarction, and stroke); all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization; hospitalization for unstable angina and grafts patency rate among 3 randomized regimens in previous DACAB trial within 5 years after CABG. The exploratory objectives are to compare the occurrence of MACE-4; MACE-5; MACE-3; all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization and hospitalization for unstable angina between 2 cohorts with or without grafts/vein grafts failure at 1 year angiographic follow-up.

Conditions

Coronary Artery Bypass Grafting; Antiplatelet Therapy

Keywords

CABG; Antiplatelet; MACE; grafts patency

Outcome Measures

Primary Outcomes (1)

• The time to the first MACE-4 event

  The time to the first occurrence of any MACE-4 event, defined as a composite of all-cause death, myocardial infarction, stroke and coronary revascularization.

  within 5 year after CABG

Secondary Outcomes (9)

• The time to the first MACE-5 event

  within 5 year after CABG

• The time to the first MACE-3 event

  within 5 year after CABG

• The time to the first occurrence of all-cause death.

  within 5 year after CABG

• The time to the first cardiovascular death

  within 5 year after CABG

• The time to the first myocardial infarction

  within 5 year after CABG

Interventions

non-interventional OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include the subjects who enrolled in DACAB trial

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (6)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450003, China

Location

Nan Jing First Hospital

Nanjing, Jiangsu, 210029, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 21002, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Zhu Y, Zhang W, Dimagli A, Han L, Cheng Z, Mei J, Chen X, Wang X, Zhou Y, Xue Q, Hu J, Tang M, Wang R, Song Y, Kang L, Redfors B, Gaudino M, Zhao Q. Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial. BMJ. 2024 Jun 11;385:e075707. doi: 10.1136/bmj-2023-075707.

  PMID: 38862179 RESULT

Study Officials

• Qiang Zhao, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Mario FL Gaudino, MD

  Weill Cornell Medicine NewYork Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD

  Ruijin Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and director, Department of Cardiac Surgery,Vice President of Ruijin Hospital

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 15, 2021
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CN (6)