Coronary artery disease MedDRA version: 16.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Efient®
Product Name: Efient®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: 274693-27-5
CAS Number: 389574-19-0
Other descriptive name: PRASUGREL HYDROCHLORIDE
Concentration unit
Sponsors
University Medical Center of the Johannes Gutenberg-University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 the three groups at 1 day, 1 week, 1 month after stenting. - To investigate the safety and tolerability of clopidogrel, prasugrel 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in L-FMC and reactive hyperemia in the three groups at 1 day, 1 week, 1 month after stenting. - 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 | — |
Countries
Germany
Contacts
Public ContactTommaso Gori
University Medical Center of the Johannes Gutenberg-University Mainz
Outcome results
None listed