Completed

ESTEffects of Clopidogrel vs Prasugel vs Ticagrelor on Endothelial Function, Inflammatory and Oxidative Stress Parameters and Platelet Function in Patients Undergoing Coronary Artery Stenting. A Randomised, Prospective Study.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Coronary stenting

+ Ticagrelor

+ Coronary stenting

ProcedureDrug
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 75 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 4
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorJohannes Gutenberg University Mainz
Last updated: September 7, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group has shown that it can be improved by platelet inhibition using clopidogrel. However, clopidogrel unresponsiveness is a known problem, and it has been show that the endothelial effects of clopidogrel tend to wane upon prolonged treatment. Whether a more effective anti-platelet therapy is able to prevent/improve not only thrombotic events but also endothelial dysfunction, with potential positive impact on clinical outcome in patients undergoing coronary artery stenting, is an important hypothesis that needs to be further investigated. To date, evidence regarding "ancillary" (non-platelet-dependent) effects of antiaggregant drugs is very limited. For instance, while their antiplatelet effects, and their beneficial effects in patients with acute coronary syndromes, have been clearly demonstrated in multicentric trials, it remains to be shown whether these drugs also protect endothelial function. Interestingly, some authors suggest that the mortality benefit observed in the PLATO study is at least in part independent of direct antiplatelet effects. No study, to date, has tested the effects of prasugrel and/or ticagrelor on endothelial function. With the present trial, the investigators plan to test the effect of clopidogrel, prasugrel and ticagrelor on endothelial function before and up to 4 weeks after coronary artery stenting. This study will provide important pathophysiologic insight on the relationship between platelet aggregation and endothelial function, two parameters that have been shown to influence patients' prognosis.

Principal SponsorJohannes Gutenberg University Mainz
Last updated: September 7, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery Disease

Criteria

5 inclusion criteria required to participate
18-75 years old consecutive patients undergoing coronary angiography and stenting at the University Medical Centre Mainz

A coronary lesion (and patient) amenable to treatment with drug eluting stent

Ability of subject to understand character and individual consequences of clinical trial

Negative pregnancy test of women with childbearing potential

Show More Criteria

22 exclusion criteria prevent from participating
Active bleeding

An acute coronary syndrome treated with coronary stenting within the last 4 weeks

Body weight < 60kg

Changes in the ß-blocker, statin or ACE or angiotensin-receptor blocker inhibitor treatment within the past 2 weeks

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Ticagrelor 180mg oral loading dose and 90mg b.i.d for 30 days following coronary artery stenting

Group II

Active Comparator
Clopidogrel 600mg loading dose + 75 mg once a day for 30 days following coronary artery stenting.

Group III

Active Comparator
Prasugrel 60mg oral loading dose followed by 10mg once a day for 30 days following coronary artery stenting

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

2 Medical Clinic

Mainz, GermanyOpen 2 Medical Clinic in Google Maps
CompletedOne Study Center