NCT03481257CompletedNot Applicable
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
Seoul National University Hospital1 site in 1 country56 target enrollmentStarted: April 12, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Occlusion time
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Occlusion time
Time Frame: 1 month
Global thrombosis test
Secondary Outcomes
- Aspirin reaction unit(Day 2 and 1 month)
- Lysis time(Day 2)
- Occlusion time(Day 2)
- P2Y12 reaction unit(Day 2 and 1 month)
Investigators
Jung-Won Suh
Principal Investigator
Seoul National University Hospital
Study Sites (1)
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