Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel
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
1 other identifier
observational
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedMarch 29, 2018
March 1, 2018
9 months
March 21, 2018
March 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Occlusion time
Global thrombosis test
1 month
Secondary Outcomes (5)
Lysis time
1 month
Occlusion time
Day 2
Lysis time
Day 2
P2Y12 reaction unit
Day 2 and 1 month
Aspirin reaction unit
Day 2 and 1 month
Other Outcomes (2)
major adverse cardiovascular outcome
1 month
BARC bleeding
1 month
Study Arms (2)
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)
Eligibility Criteria
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)
You may qualify if:
- Patients who were diagnosed with acute coronary syndrome and underwent percutaneous coronary intervention
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung-Won Suh
Seoul National University Bundang Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 21, 2018
First Posted
March 29, 2018
Study Start
April 12, 2017
Primary Completion
January 4, 2018
Study Completion
February 4, 2018
Last Updated
March 29, 2018
Record last verified: 2018-03