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NCT03481257 Clinical Trial

Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

Acute Coronary Syndrome Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03481257
Other study ID # 06-2017-086
Secondary ID
Status Completed
Phase
First received March 21, 2018
Last updated March 28, 2018
Start date April 12, 2017
Est. completion date February 4, 2018

Study information
Verified date March 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date February 4, 2018
Est. primary completion date January 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other major adverse cardiovascular outcome composites of cardiac death, myocardial infarction and target lesion revascularization 1 month
Other BARC bleeding ARC definition 1 month
Primary Occlusion time Global thrombosis test 1 month
Secondary Lysis time Global thrombosis test 1 month
Secondary Occlusion time Global thrombosis test Day 2
Secondary Lysis time Global thrombosis test Day 2
Secondary P2Y12 reaction unit VerifyNow test Day 2 and 1 month
Secondary Aspirin reaction unit VerifyNow test Day 2 and 1 month
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