Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

NCT ID: NCT03481257

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-12

Study Completion Date

2018-02-04

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ticagrelor

ACS patients treated with aspirin (100mg/d) and ticagrelor (90mg bid)

No interventions assigned to this group

Clopidogrel + very low dose rivaroxaban

ACS patients treated with aspirin (100mg/d), clopidogrel(75mg/d) and very low dose rivaroxaban (2.5mg bid)

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Suh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Won Suh

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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06-2017-086

Identifier Type: -

Identifier Source: org_study_id

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