Endothelial Funkction after Stenting.

• Conditions: Coronary artery disease; MedDRA version: 16.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005305-73-DE
• Lead Sponsor: niversity Medical Center of the Johannes Gutenberg-University Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-03
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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
- Signed and dated informed consent of the subject must be
available before start of any specific trial procedures.
- Negative pregnancy test of women with childbearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Patients with elevated (>5 times upper normal limit) C-reactive
protein level prior to stenting and an acute infection (elevated CRP in context of ACS is not an exclusion criteria)
- Patients in whom therapy with long-acting nitrates cannot be
suspended prior to endothelial function measurements
- An acute coronary syndrome treated with coronary stenting within the last 4 weeks
- Patients with known inflammatory/infective diseases
- Patients with severe extracardiac diseases limiting life expectancy
- Known heart failure (LV-EF =40% AND NYHA III-IV)
- PCI or coronary By-Pass surgery within the last 4 weeks, preexisting ongoing treatment with any of the study treatments.
- History of cerebrovascular events (stroke)
- Known renal dysfunction (serum creatinine =1.8mg/dl in women, =2.0mg/dl in men)
- Serum potassium >5.5mmol/l
- Known hepatic impairment (AST, ALT >3 times upper limit of
normal)
- Changes in the ß-blocker, statin or ACE-inhibitor treatment within the past 2 weeks
- Pregnancy and lactation, inadequate contraception
- Body weight <60kg
- Active bleeding
- Therapy with CYP3A4 inhibitors (ketoconazole, protease inhibitors, macrolide antibiotics)
- Therapy with anticoagulants: phenprocoumone, warfarin,
dabigatran, rivaroxaban
- History of hypersensitivity to any of the investigational medicinal
products or to any drug with similar chemical structure or to any
excipient present in the pharmaceutical form of the investigational
medicinal product.
- Ongoing participation in other clinical trials or within the last 3
months, or ongoing therapy with one of the study medications.
- Medical or psychological condition that would not permit
completion of the trial or signing of informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to investigate the impact of the three treatments under study on endothelial function as assessed by flowmediated dilation (FMD) in patients who have undergone stenting.;Secondary Objective: - To investigate the changes in L-FMC and reactive hyperemia in<br>the three groups at 1 day, 1 week, 1 month after stenting.<br>- To investigate the safety and tolerability of clopidogrel, prasugrel<br>and ticagrelor;Primary end point(s): The primary endpoint is the mean FMD across the three measurements (1day, 1week, 1month) performed after coronary artery stenting.;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 1 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Changes in L-FMC and reactive hyperemia in the three groups at<br>1 day, 1 week, 1 month after stenting.<br>- Safety and tolerability of clopidogrel, prasugrel and ticagrelor;Timepoint(s) of evaluation of this end point: immediately after administration, 1 day, 1 week, 1 month