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Completed

NCT Number: NCT01957527

Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)

Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).

This is a prospective, observational study, which will be conducted in patients with coronary artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0 for genotype analysis.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age above 18-80 years old
  • Patients with Coronary Artery Disease receiving ticagrelor maintenance dose (MD) 90mg x 2 and are about to discontinue the treatment due to the completion of 1 year of dual antiplatelet therapy.
  • Patients giving written Informed Consent.

Exclusion criteria

  • Acute Coronary Syndrome
  • Foreseeable need for anticoagulant treatment within the next 5 days
  • Severe non-regulated with theophylline/aminophylline administration chronic obstructive pulmonary disease
  • Creatinine Clearance <30ml/min/1.73mm2
  • HbA1c > 10mg/dl

Treatment and study plan

Peripheral arterial tonometry (EndoPAT)

Device

Primary outcomes

  1. Reactive Hyperemia Index (RHI) on Day 0 and on Day 5

    Time frame: 5 days

    Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 5

Secondary outcomes

  1. Reactive Hyperemia Index (RHI) on Day 0 and on Day 2

    Time frame: 2 days

    Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 2

  2. Reactive Hyperemia Index (RHI) on Day 2 and on Day 5

    Time frame: 3 days

    Reactive Hyperemia Index (RHI) on Day 2 will be compared to RHI on Day 5

  3. The percentage of patients with RHI<1.67 on Day 0 and on Day 5

    Time frame: 5 days

  4. The percentage of the patients with RHI<1.67 on Day 0 and on Day 2

    Time frame: 2 days

  5. The percentage of the patients with RHI<1.67 on Day 2 and on Day 5

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
Aug 20, 2015

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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