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Trial record 65 of 508 for:    ASPIRIN AND P2

Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

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ClinicalTrials.gov Identifier: NCT03481257
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jung-Won Suh, Seoul National University Hospital

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.

Condition or disease
Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : February 4, 2018

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Occlusion time [ Time Frame: 1 month ]
    Global thrombosis test


Secondary Outcome Measures :
  1. Lysis time [ Time Frame: 1 month ]
    Global thrombosis test

  2. Occlusion time [ Time Frame: Day 2 ]
    Global thrombosis test

  3. Lysis time [ Time Frame: Day 2 ]
    Global thrombosis test

  4. P2Y12 reaction unit [ Time Frame: Day 2 and 1 month ]
    VerifyNow test

  5. Aspirin reaction unit [ Time Frame: Day 2 and 1 month ]
    VerifyNow test


Other Outcome Measures:
  1. major adverse cardiovascular outcome [ Time Frame: 1 month ]
    composites of cardiac death, myocardial infarction and target lesion revascularization

  2. BARC bleeding [ Time Frame: 1 month ]
    ARC definition



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481257


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jung-Won Suh Seoul National University Bundang Hospital

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Responsible Party: Jung-Won Suh, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03481257     History of Changes
Other Study ID Numbers: 06-2017-086
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Rivaroxaban
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors