Patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI). MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
German Heart Centre Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Men and women >18 years of age - Diagnosis: Clinically stable coronary artery disease - Angiographic evidence of coronary artery disease - Indication for PCI 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 222
Exclusion criteria
Exclusion criteria: - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product. - Women who are pregnant or breastfeeding or are planning pregnancy during course of trial - Women with a positive pregnancy test on enrolment or prior to investigational product administration. - Patients with elevated high sensitivity cardiac troponin T levels at screening - Patients receiving antithrombotic therapy with Prasugrel or Ticagrelor within 7 days prior to randomisation - History of hypersensitivity, contraindication or serious adverse reaction to any component of the study drug (GPVI-Fc, sucrose, mannitol), acetylsalicylic acid or clopidogrel - History of bleeding diathesis or active bleeding within the last 30 days - Recent intracerebral haemorrhage or trauma within the last 3 months - Thrombocytopenia (platelet count 179mmHg or diastolic BP >109mmHg) at screening - Renal failure (estimated glomerular filtration rate 5-fold the upper normal range limit) - Patients with an indication for anticoagulant therapy - Participation in any other clinical interventional trial (drug/device) within less than 30 days prior to screening - Any other contraindication to perform PCI - Any planned additional PCI or surgery within 30 days after randomisation - Suspected poor capability to follow instructions and cooperate - Prisoners or subjects who are involuntarily incarcerated - Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoint of the study is an composite endpoint of death or or myocardial injury (defined as increase in cardiac biomarker high sensitivity cardiac Troponin T of at least 5 times the upper limit of norm) within 48 hours from randomisation.;Secondary Objective: Secondary endpoints - Peak high-sensitivity troponin T level within 48 hours from randomisation to be evaluated within 30 days after randomisation: - All-cause mortality - Myocardial infarction - PCI-related (type4a) myocardial infarction - Definite stent thrombosis - Urgent coronary revascularization - Stroke - Bleeding complication class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint) ;Primary end point(s): Primary endpoint of the study is an composite endpoint of death or or myocardial injury (defined as increase in cardiac biomarker high sensitivity cardiac Troponin T of at least 5 times the upper limit of norm) within 48 hours from randomisation.;Timepoint(s) of evaluation of this end point: Baseline to within 48 hours from randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints - Peak high-sensitivity troponin T level within 48 hours from randomisation to be evaluated within 30 days after randomisation: - All-cause mortality - Myocardial infarction - PCI-related (type4a) myocardial infarction - Definite stent thrombosis - Urgent coronary revascularization - Stroke - Bleeding complication class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint) ;Timepoint(s) of evaluation of this end point: Baseline to 30 days from randomisation for secondary endpoints. | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Adnan Kastrati
German Heart Centre Munich
Outcome results
None listed