Comparison Between Ticagrelor Versus Very Low Dose Rivaro... | NCT03481257

Studies
Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

NCT03481257

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 29, 2018Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome
Acute Myocardial Infarction
Unstable Angina

Interventions

Not provided

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

Mar 2018

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

Apr 12, 2017Actual

Primary Completion Date

Jan 4, 2018Actual

Completion Date

Feb 4, 2018Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Mar 28, 2018

First Posted Date

Mar 29, 2018Actual

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

Mar 28, 2018

Last Update Posted Date

Mar 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung-Won Suh, Principal Investigator, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

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

A total of 50 participants diagnosed with ACS (group A ticagrelor 180mg/d, n=25), group B (clopidogrel 75mg + rivaroxaban 5mg/ d, n=25)) were consecutively enrolled and treated with study drugs on top of aspirin (100mg/d) for 1 month. VerifyNow® and Global thrombosis test were performed at day 2 and 1 month after administration of study drugs. The investigators compared aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU), occlusion time (OT) which reflects shear stress-induced thrombotic activity, and lysis time (LT) which showed endogenous lytic activity between the two strategies at both time points.

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

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ticagrelor		ACS patients treated with aspirin (100mg/d) and ticagrelor (90mg bid)
Clopidogrel + very low dose rivaroxaban		ACS patients treated with aspirin (100mg/d), clopidogrel(75mg/d) and very low dose rivaroxaban (2.5mg bid)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occlusion time	Global thrombosis test	1 month

Secondary Outcomes

Measure	Description	Time Frame
Lysis time	Global thrombosis test	1 month
Occlusion time	Global thrombosis test	Day 2

Other Outcomes

Measure	Description	Time Frame
major adverse cardiovascular outcome	composites of cardiac death, myocardial infarction and target lesion revascularization	1 month
BARC bleeding	ARC definition

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who were diagnosed with acute coronary syndrome and underwent percutaneous coronary intervention

Exclusion Criteria:

Patients administered with glycoprotein IIb/IIIa inhibitiors
Patients with atrial fibrillation
Patients with high risk of bleeding at the physician's discretion
Patients with renal impairment (estimated GFR <30ml/min)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Fifty-six patients from 452 patients who underwent percutaneous coronary intervention (PCI) due to ACS in Seoul National University Bundang Hospital. ( April 2017~ January 2018)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung-Won Suh	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463707	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D000789	Angina, Unstable

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided