Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery

NCT02201771 | Completed Phase 4 Results

• 1 other identifier: ISSBRIL0211
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Bypass; Antiplatelet Agents

Keywords

CABG; Antiplatelet; Ticagrelor

Outcome Measures

Primary Outcomes (1)

• The Patency of Saphenous Vein Grafts

  assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis \<50%) is defined as "patency".

  up to 12 months

Secondary Outcomes (5)

• The Patency of Saphenous Vein Grafts

  up to 7 days

• The Rate of Post-operative Atrial Fibrillation After CABG.

  up to 7 days

• The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification

  up to 12 months

• The Number of Major Adverse Cardiovascular Event (MACE)

  up to 12 months

• Number of the Major Bleeding Events

  up to 12 months

Other Outcomes (1)

• The Rate of Gastroduodenal Injury Assessed by Esophagogastroduodenoscopy (EGD)

  at 12 months

Study Arms (3)

Aspirin

ACTIVE COMPARATOR

aspirin 100mg tablet by mouth daily for 12 months

Drug: Aspirin

Ticagrelor plus Aspirin

EXPERIMENTAL

ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months

Drug: Aspirin; Drug: Ticagrelor

Ticagrelor

EXPERIMENTAL

ticagrelor 90mg tablet by mouth twice daily for 12 months

Drug: Ticagrelor

Interventions

Aspirin DRUG

Aspirin; Ticagrelor plus Aspirin

Ticagrelor DRUG

Ticagrelor; Ticagrelor plus Aspirin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (6)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nan Jing First Hospital

Nanjing, Jiangsu, 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)

• Zhao Q, Zhu Y, Xu Z, Cheng Z, Mei J, Chen X, Wang X. Effect of Ticagrelor Plus Aspirin, Ticagrelor Alone, or Aspirin Alone on Saphenous Vein Graft Patency 1 Year After Coronary Artery Bypass Grafting: A Randomized Clinical Trial. JAMA. 2018 Apr 24;319(16):1677-1686. doi: 10.1001/jama.2018.3197.

  PMID: 29710164 DERIVED

MeSH Terms

Interventions

Aspirin; Ticagrelor

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Yunpeng Zhu
• Organization: Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

zypB1014@rjh.com.cn

008613816819346

Study Officials

• Qiang Zhao, MD.PhD

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD.

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Ruijin Hospital, Professor and director, Department of Cardiac Surgery

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 13, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-08

Locations

CN (6)