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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957527
• Other study ID #: PATRASCARDIOLOGY-15
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2013
• Last updated: August 19, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age above 18-80 years old

2. 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.

3. Patients giving written Informed Consent.

Exclusion Criteria:

1. Acute Coronary Syndrome

2. Foreseeable need for anticoagulant treatment within the next 5 days

3. Severe non-regulated with theophylline/aminophylline administration chronic obstructive pulmonary disease

4. Creatinine Clearance <30ml/min/1.73mm2

5. HbA1c > 10mg/dl

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Endothelial Function
• Myocardial Ischemia

Intervention

Device:
• Peripheral arterial tonometry (EndoPAT)

Locations

Country	Name	City	State
Greece	Patras University Hospital	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive Hyperemia Index (RHI) on Day 0 and on Day 5	Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 5	5 days	No
Secondary	Reactive Hyperemia Index (RHI) on Day 0 and on Day 2	Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 2	2 days	No
Secondary	Reactive Hyperemia Index (RHI) on Day 2 and on Day 5	Reactive Hyperemia Index (RHI) on Day 2 will be compared to RHI on Day 5	3 days	No
Secondary	The percentage of patients with RHI<1.67 on Day 0 and on Day 5		5 days	No
Secondary	The percentage of the patients with RHI<1.67 on Day 0 and on Day 2		2 days	No
Secondary	The percentage of the patients with RHI<1.67 on Day 2 and on Day 5		3 days	No