Compare Ticagrelor vs Clopidogrel on the Reduction of Arterial Stiffness and Wave Reflectionsin Patients With CAD. — NOVELTY  

Coronary Artery Disease Clinical Trial

Official title: A Single Center Phase II Assessor-Blinded RaNdomised Active Controlled Parallel-Group Trial to COmpare Ticagrelor Versus Clopidogrel on the REduction of ArteriaL STiffness and Wave Reflections in Patients With CoronarY Artery Disease.

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the potential acute and chronic effect of ticagrelor versus clopidogrel on arterial stiffness and other vascular risk markers of interest, the study will consist of two periods: a 24-hour ACUTE period where 60 subjects with an indication for coronary angiography (CA) with or without percutaneous coronary intervention (PCI) will be included, and a 30-day CHRONIC period where approximately 60 subjects that will undergo PCI will be included and studied (refer to Section 3 'Study Plan and Procedures'). The primary objective of this study is to compare ticagrelor versus clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after the loading dose of each regimen, in eligible subjects with CAD.

Clinical Trial Description

This is singe-center, randomized, assessor-blinded, active controlled, parallel-group trial consisting of an 'acute' and a 'chronic' period, aiming at comparing ticagrelor versus clopidogrel on the reduction of arterial stiffness and wave reflections in patients with CAD. This Investigator-Sponsored Study (ISS) will be supported by AstraZeneca.

60 subjects fulfilling all study-specific eligibility criteria will be initially recruited for the 'acute' study period of 24-hour duration. Subjects that will undergo ad hoc PCI will continue in the subsequent 'chronic' study period of 30-day duration.

In order to have 60 subjects in the 'chronic' study period (since some of the 'acute' period will not undergo PCI), additional subjects that are scheduled for elective PCI will be recruited until the sample size of 'chronic' study period reaches 60 subjects.

The study periods [Figure 1, Flow Chart] have as follows:

For the 24-hour ACUTE period, 60 subjects with an indication for elective CA with or without PCI will be included in the study.

Three (3) hours before the CA the subjects will be randomized in the two study treatment arms:

Ticagrelor arm: 30 subjects will receive

• 180 mg loading dose of ticagrelor,

• 1st maintenance ticagrelor dose of 90 mg at 12 hours. Clopidogrel arm: 30 subjects will receive

• 600 mg loading dose of clopidogrel.

Study measurements (arterial stiffness, central blood pressure and endothelial function) for both study treatment arms will be performed at:

• baseline (0 hours - prior to the loading dose administration)

• 3 hours (after the loading dose of each regimen and before CA), and at

• 24 hours (before the administration of the 2nd maintenance dose of ticagrelor and the 1st maintenance dose of clopidogrel).

For the 30-day CHRONIC period, 60 subjects that will undergo PCI (stent implantation) will be studied. Part of this 'chronic' period population will consist of the subjects that were included in the 'acute' period and proceeded ad hoc to PCI. The remainder will be subjects being scheduled for elective PCI, who will be enrolled after the completion of the recruitment in the 'acute' study period.

Approximately 30 subjects will be allocated to ticagrelor loading dose and maintenance dose (90 mg BID) thereafter and approximately 30 subjects will be allocated to 600 mg of clopidogrel and maintenance dose (75 mg QD) thereafter.

Study measurements for the subjects of the 'acute' period that will enter the 'chronic' period will be performed at:

• 30 days post-PCI (prior to the administration of the morning maintenance dose of the assigned treatment regimen at the day of study visit).

Study measurements for the additional subjects with indication of elective PCI that will be enrolled directly into the chronic study period will be performed at:

• baseline (0 hours - prior to the administration of the loading dose of each treatment regimen and 3 hours before the PCI)

• 30 days post PCI (prior to the administration of the morning maintenance dose of the assigned treatment regimen at the day of study visit).

All study-related procedures will be carried out in accordance with the institutional guidelines and common practice. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT02071212
• Study type: Interventional
• Source: Hellenic Cardiovascular Research Society
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Completion date: June 2018