E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI). |
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E.1.1.1 | Medical condition in easily understood language |
Patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 <30000/mm3) at screening - Sustained hypertension (systolic BP >179mmHg or diastolic BP >109mmHg) at screening - Renal failure (estimated glomerular filtration rate < 30ml/min and/or dialysis) - Severe systemic disease, such as known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance - Unable to provide informed consent (e.g. severe dementia, or psychosis) - Current severe liver dysfunction (transaminase level >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)
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to within 48 hours from randomisation. |
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E.5.2 | 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)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline to 30 days from randomisation for secondary endpoints.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |