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OpenTrials
Completed

NCT Number: NCT03481257

Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel

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.

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Key information

Conditions

Acute Coronary Syndrome Acute Myocardial Infarction Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Occlusion time

    Time frame: 1 month

    Global thrombosis test

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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