E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute coronary syndrome (ACS) with or without ST-segment elevation who undergo CATH ± PCI |
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E.1.1.1 | Medical condition in easily understood language |
Patients with acute miocardial infarction with or without ST-segment elevation who undergo CATH and if necessary 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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071111 |
E.1.2 | Term | Non ST segment elevation acute coronary syndrome |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064346 |
E.1.2 | Term | STEMI |
E.1.2 | System Organ Class | 100000004849 |
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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 |
To demonstrate that the transradial access site or infusion of bivalirudin compared to femoral access or standard therapy consisting of unfractionated heparin and glycoprotein inhibitors use provusionale IIb / IIIa are associated with a lower incidence of the composite of death, myocardial infarction and stroke within 30 days after randomization in patients with acute coronary syndrome exposed to early invasive treatment. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1. PRU Matrix Substudy - Customized Choice of P2Y12 oral receptor blocker based on an integrated algorithm of phenotype assessment via Point of care testing Objectives:To demonstrate in ACS patients undergoing early percutaneous intervention that an algorithm to select the most proper oral P2Y12 blocker integrating phenotype information will result in a lower composite endpoint of cardiovascular death, myocardial infarction, stroke or BARC defined bleeding type 2 or 3 at 1 year follow-up compared to standard of care. 2. OPTICAL COHERENCE TOMOGRAPHY (OCT) SUB-STUDY Objectives: The use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by OCT at the end of procedure and at 3-5 days follow-up, in patients affected by STEMI, treated by primary PCI and showing multivessel disease suitable for staged PCI. 3. RADIATION DOSE SUB-STUDY Objectives: Aim of our study is to evaluate the radiation dose adsorbed by operators during percutaneous coronary procedures in the setting of acute coronary syndromes comparing the transradial and the transfemoral approach. Moreover we will also evaluate the radiation dose adsorbed by operators during right or left transradial approach.
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E.3 | Principal inclusion criteria |
All patients with acute coronary syndrome (ACS) who undergo angiography coronary angioplasty В ± (CIP) will be enrolled on consecutive basic. ACS with or without ST-segment elevation are eligible for treatment with both access sites trans-radial and trans-femoral. |
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E.4 | Principal exclusion criteria |
1.Patients who can not give informed consent or have a life expectancy of <30 days. 2.Allergy/intolerance to bivalirudin or unfractionated heparin. 3.Stable or silent CAD as indication to coronary angiography. 4.Treatment with LWMH within the past 6 hours. 5.Treatment with any GPI in the previous 3 days. 6.Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including both aspirin and clopidogrel. 7.Contraindications to angiography, including but not limited to severe peripheral vascular disease. 8.If it is known, pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant. 9.If it is known, a creatinine clearance <30 mL/min or dialysis dependent. 10.Previous enrolment in this study. 11.Treatment with other investigational drugs or devices within the preceding 30 days. 12.Randomisation or planned use of other investigational drugs or devices in this trial. 13.Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment). 14.Subacute bacterial endocarditis. 15.PCI in the previous 30 days.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint at 30 days: • A composite of death, re-infarction (MI) or stroke
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Key Secondary Endpoints: A composite of death, non-fatal MI, stroke or BARC-defined type 3 and 5 major bleeding complications at 30 days.
Main Secondary Endpoints: 1)The rate of each component of the composite endpoint of the primary or the key secondary endpoint at 30 days and 1 year analyzed in various study populations including the ITT and PP access site group both in the whole recruited patient population (i.e. including patients who underwent angiography only) and in those who finally underwent PCI and in the ITT and PP pharmacology arm both in the whole recruited patient population (i.e. including patients who underwent angiography only) and in those who finally underwent PCI, stratified based on actual use of GPI in the reference group. 2)The rate of stent thrombosis at any time during follow-up and the rate of urgent target vessel revascularization up to 30 days. 3)The rate of procedural success defined as final TIMI 3 flow and a residual coronary stenosis of less than 30% at visual estimation. 4)TIMI major or minor bleeding events and net clinical outcomes (defined as the composite of death, MI, stroke and TIMI minor or major bleedings according to TIMI) and the rate of thrombocytopenia. 5)The length and costs of hospitalization as well as cost-effectiveness of transradial intervention versus transfemoral and bivalirudin versus UFH±GPI. 6)The need for surgical access site repair/intervention and/or blood products transfusion 7)The prognostic impact of bleeding complications on 30 days death, MI or stroke rate as assessed based on various bleeding classifications including BARC, TIMI and GUSTO as well as the prognostic role of thrombocytopenia. 8)The prognostic value of on-treatment P2Y12 platelet residual activity measured via a point-of-care instruments at the time or immediately after PCI
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |