Comparison of CABG Related Bleeding Complications in Pati... | NCT04431349

Studies
Comparison of CABG Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel

NCT04431349

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Jun 16, 2020Actual

Enrollment

1,097Actual

Phase

Not provided

Conditions

Blood Loss, Surgical
Ticagrelor
Clopidogrel

Interventions

Ticagrelor 180mg
Clopidogrel 75mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

May 6, 2020Actual

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2020

Last Update Posted Date

Jun 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiyoung Yoo, Assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and a P2Y12-receptor antagonist) is a commonly used method because of its excellent antithrombotic effect. In particular, in patients with acute myocardial infarction, who receive coronary angiography as an emergency, the dual antiplatelet is used immediately before the test to prevent and test further clot formation, regardless of whether or not the patient had previously taken dual antiplatelet.

Ticagrelor, a direct-acting and reversible ADP receptor antagonist, was introduced in Denmark in 2013 and is now the most commonly used ADP receptor antagonist in the treatment of ACS. Compared to its predecessor clopidogrel, the pharmacokinetic proﬁl of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days.

Most patients who receive emergency coronary heart surgery after undergoing coronary angiography as an emergency due to an acute myocardial infarction, it take approximately 24-48 hours to undergo surgery after examination. In fact, there have been reports of large-scale cross-country studies that do not increase bleeding risk compared to 5 days until 3 days after ticagrelor is stopped. Therefore, this study aimed to retrospectively analyze the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in preoperative coronary angiography for patients undergoing emergency CABG surgery from 2016 to September 2019.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,097Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ticagrelor		The patient with acute myocardial infarction received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.	Drug: Ticagrelor 180mg
clopidogrel		The patient with acute myocardial infarction received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.	Drug: Clopidogrel 75mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor 180mg	Drug	Patient received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.	ticagrelor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major bleeding event	major bleeding defined as BARC-CABG related bleeding	within 48hours after operation

Secondary Outcomes

Measure	Description	Time Frame
RBC transfusion amount	total amount of RBC transfusion within hospital stay after operation	through study completion, an average of 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient with acute myocardial infarction received loading dose of clopidogrel or ticagrelor for coronary angiography within 2 days prior to emergency OPCAB or CABG.

Exclusion Criteria:

heart surgery combined with other operation (valve surgery, aorta surgery, trauma surgery)
History of coagulopathy
History of liver cirrhosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Emergency OPCAB or CABG surgery in Ajou university hospital from January 2016 to September 2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou University Hospital		Suwon	Gyeonggido		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016063	Blood Loss, Surgical

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007431	Intraoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077486	Ticagrelor
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided