Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

March 28, 2018 updated by: Jung-Won Suh, Seoul National University Hospital

Comparison of Shear Stress-induced Thrombotic and Thrombolytic Effect d Thrombolytic Effect Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel in Patients With Acute Coronary Syndrome

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusion time
Time Frame: 1 month
Global thrombosis test
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysis time
Time Frame: 1 month
Global thrombosis test
1 month
Occlusion time
Time Frame: Day 2
Global thrombosis test
Day 2
Lysis time
Time Frame: Day 2
Global thrombosis test
Day 2
P2Y12 reaction unit
Time Frame: Day 2 and 1 month
VerifyNow test
Day 2 and 1 month
Aspirin reaction unit
Time Frame: Day 2 and 1 month
VerifyNow test
Day 2 and 1 month

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jung-Won Suh, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

January 4, 2018

Study Completion (Actual)

February 4, 2018

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-2017-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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